Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial (CLASP IID/IIF)

• ClinicalTrials.gov Identifier: NCT03706833
• Recruitment Status: Recruiting
• First Posted: October 16, 2018
• Last Update Posted: March 2, 2023
• Sponsor: Edwards Lifesciences
• Information provided by (Responsible Party): Edwards Lifesciences

Study Description

Brief Summary:

To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)

Condition or disease	Intervention/treatment	Phase
Degenerative Mitral Valve Disease; Mitral Regurgitation; Mitral Insufficiency; Functional Mitral Regurgitation	Device: Edwards PASCAL System; Device: Abbott Mitraclip System	Not Applicable

Detailed Description:

A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to Abbott MitraClip in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)

Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 5 years.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1247 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP IID/IIF): A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Mitral Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System Compared to Abbott MitraClip in Patients With Mitral Regurgitation
• Actual Study Start Date: November 30, 2018
• Estimated Primary Completion Date: December 31, 2023
• Estimated Study Completion Date: January 31, 2028

Arms and Interventions

Arm	Intervention/treatment
Experimental: Edwards PASCAL System - CLASP IID; Transcatheter mitral valve repair with the Edwards PASCAL System in patients with degenerative mitral regurgitation	Device: Edwards PASCAL System; Transcatheter mitral valve repair with the Edwards PASCAL System; Other Name: Transcatheter Mitral Valve repair (TMVr)
Active Comparator: Abbott Mitraclip System - CLASP IID; Transcatheter mitral valve repair with the Abbott Mitraclip System in patients with degenerative mitral regurgitation	Device: Abbott Mitraclip System; Transcatheter mitral valve repair with the Abbott Mitraclip System; Other Name: Transcatheter Mitral Valve repair (TMVr)
Experimental: Edwards PASCAL System - CLASP IIF; Transcatheter mitral valve repair with the Edwards PASCAL System in patients on guideline directed medical therapy with functional mitral regurgitation	Device: Edwards PASCAL System; Transcatheter mitral valve repair with the Edwards PASCAL System; Other Name: Transcatheter Mitral Valve repair (TMVr)
Active Comparator: Abbott Mitraclip System - CLASP IIF; Transcatheter mitral valve repair with the Abbott Mitraclip System in patients on guideline directed medical therapy with functional mitral regurgitation	Device: Abbott Mitraclip System; Transcatheter mitral valve repair with the Abbott Mitraclip System; Other Name: Transcatheter Mitral Valve repair (TMVr)
Experimental: Edwards PASCAL System - Single-Arm Registry; Transcatheter mitral valve repair with the Edwards PASCAL System in patients with mitral regurgitation who were deemed non-randomizable by a central screening committee (CSC) due to complex anatomical features described in the current MitraClip Instructions for Use (IFU) but were considered suitable for the PASCAL system.	Device: Edwards PASCAL System; Transcatheter mitral valve repair with the Edwards PASCAL System; Other Name: Transcatheter Mitral Valve repair (TMVr)

Outcome Measures

Primary Outcome Measures :

1. PASCAL is not inferior to MitraClip with respect to the proportion of patients with major adverse events (MAE). The primary safety endpoint is a composite of Major Adverse Events (MAEs). [ Time Frame: 30 days. ]
2. PASCAL is not inferior to Mitraclip with respect to the proportion of patients with MR severity reduction as measured by echocardiography using a scale of 0-4+ for the CLASP IID Cohort. [ Time Frame: 6 months ]
3. PASCAL is not inferior to Mitraclip with respect to the time to first heart failure hospitalization or death for the CLASP IIF Cohort only. [ Time Frame: From date of randomization until date of first heart failure hospitalization or death, through 5 year follow-up ]

Secondary Outcome Measures :

1. Rates of various adverse events [ Time Frame: 6 months; 12 months ]
   Rates of various adverse events at 6 and 12 months
2. Functional Improvement (increase in 6 minute walk test in meters) [ Time Frame: 30 days , 6 months, 1 year ]
   Increase in 6 minute walk test in meters
3. Functional improvement (quality of life) as assessed using the Kansas City Cardiomyopathy Questionnaire through 2 years [ Time Frame: 30 days , 6 months, 1 year, 2 year ]
   Number of points of improvement on a scale of 0-100 in Kansas City Cardiomyopathy Questionnaire, with higher scores associated with higher Quality of Life
4. Functional improvement (quality of life) as assessed by number of points of improvement on the Short Form Health Survey (SF-36) questionnaire through 2 years [ Time Frame: 30 days, 6 months, 1 year, 2 year ]
   Number of points of improvement on a scale of 0-100 in Short Form Health Survey (SF-36) questionnaire, with higher totals associated with higher Quality of Life
5. Functional improvement (quality of life) as assessed by number of points of improvement on the Short Form Health Survey (EQ-5D-5L) questionnaire through [ Time Frame: 30 days, 6 months, 1 year, 2 year ]
   Number of points of improvement on a scale of 1-100 in Short Form Health Survey (EQ-5D-5L) questionnaire, with higher totals associated with higher Quality of Life

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Eighteen (18) years of age or older
• Patient is able and willing to give informed consent and follow protocol procedures, and comply with follow-up visit requirements.
• Patient is determined to be at prohibitive risk for mitral valve surgery by the heart team (CLASP IID cohort only).
• Patient is on stable heart failure medications/Guideline Directed Medical Therapy (CLASP IIF cohort only)
• Patient is determined to be a candidate for transcatheter mitral valve repair by the heart team for both PASCAL and MitraClip
• Mitral regurgitation (3+ to 4+) by echo
• Suitable valve and regurgitant jet morphology
• Elevated corrected BNP > 400 pg/ml or corrected NT-pro BNP of > 900 pg/ml or heart failure hospitalization within the past 12 months (CLASP IIF cohort only)
• LVEF ≥ 20% (and ≤ 50%; CLASP IIF cohort only)

Exclusion Criteria:

• Patient in whom a TEE is contraindicated or screening TEE is unsuccessful
• Mitral valve anatomy which may preclude proper PASCAL or MitraClip access, use and/or deployment or sufficient reduction in mitral regurgitation
• Patient with refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, Status ≤5 heart transplantation) (ACC/AHA Stage D heart failure)
• Clinically significant, untreated coronary artery disease
• Recent stroke
• Other severe valve disorders requiring intervention
• Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months
• Any prior mitral valve surgery or transcatheter mitral valve procedure (excluding chordal replacement or surgical annuloplasty repair)
• Severe tricuspid regurgitation or tricuspid valve disease requiring surgery
• Active rheumatic heart disease or rheumatic etiology for MR
• Severe aortic stenosis or regurgitation
• Known history of untreated, severe carotid stenosis
• Recent deep vein thrombosis (DVT) or pulmonary embolism (PE)
• Severe COPD
• Pregnant or planning pregnancy within next 12 months. Note: Female patients of childbearing potential need to have a negative pregnancy test performed within 14 days prior to intervention and be adherent to an accepted method of contraception
• Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
• Patient is currently participating in another investigational biologic, drug or device clinical study where the primary study endpoint was not reached at time of enrollment
• Other medical, social, or psychological conditions that preclude appropriate consent and follow-up, including patients under guardianship

Contacts and Locations

Contacts

Contact: Edwards TMTT Clinical Affairs; (949) 250-2500; TMTT_Clinical@edwards.com

Locations

United States, Alabama

The University of Alabama at Birmingham; Recruiting

Birmingham, Alabama, United States, 35233

Contact: Sarah Houston 205-934-5774 scarlson@uabmc.edu

Contact: Patrick Frazier 205-934-5774 thomasfrazier@uabmc.edu

Principal Investigator: Mustafa Ahmed, MD

Sub-Investigator: Andrew Lenneman, MD

Sub-Investigator: Panayotis Vardas, MD

United States, Arizona

Banner University Medical Center; Recruiting

Phoenix, Arizona, United States, 85006

Contact: Jessica Graves 425-829-3581 Jessicagraves@arizona.edu

Contact: Tera Wolf 602-690-6316 terawolf@arizona.edu

Principal Investigator: Marvin Eng, MD

Sub-Investigator: Prakash Balan, MD

Sub-Investigator: Philip Gideon, MD

Sub-Investigator: Nickalaus Gramze, MD

Abrazo Arizona Heart Hospital; Recruiting

Phoenix, Arizona, United States, 85016

Contact: Jessica Byrne 602-952-0002 ext 7349 Jessica.byrne@abrazohealth.com

Contact: Tamera Querrey 620-952-0002 Taquerrey@abrazohealth.com

Principal Investigator: Timothy Byrne, MD

Sub-Investigator: Akil Loli, MD

Sub-Investigator: Merick Kirshner, MD

Sub-Investigator: Robert Shull, MD

Arizona Cardiovascular Research Center; Recruiting

Phoenix, Arizona, United States, 85016

Contact: Revathy Vilasan 602-456-2342 Rvilasan@azheartrhythm.com

Contact: Jay Gutta 602-456-2342 Jgutta@azheartrhythm.com

Principal Investigator: Hursh Naik, MD

Sub-Investigator: Vijendra Swarup, MD

Sub-Investigator: Travis Warner, MD

Sub-Investigator: Rajakrishnan Vijayakrishnan, MD

TMC Healthcare; Recruiting

Tucson, Arizona, United States, 85712

Contact: Natalia Elias-Calles 520-324-5512 Natalia.eliascalles@tmcaz.com

Contact: Samantha Castro 520-324-1560 Samantha.Castro@tmcaz.com

Principal Investigator: Thomas Waggoner, DO

Principal Investigator: Neil Gheewala, MD

Sub-Investigator: Nader Makki, MD

Sub-Investigator: Gregory Franklin, MD

Sub-Investigator: Kushagra Katariya, MD

United States, California

PIH Health Good Samaritan Hospital; Recruiting

Los Angeles, California, United States, 90017

Contact: Andrea Lona 213-977-2121 ext 2584 Andrea.lona@pihhealth.org

Principal Investigator: Steven Burstein, MD

Sub-Investigator: Bruce Macrum, MD

Sub-Investigator: Joe Rahman, MD

Cedars Sinai Medical Center; Recruiting

Los Angeles, California, United States, 90048

Contact: Mitch Gheorghiu 310-423-6152 Mitch.Gheorghiu@cshs.org

Contact: Kelly Salazar 310-967-4375 Kelly.Salazar@cshs.org

Principal Investigator: Raj Makkar, MD

Sub-Investigator: Alfredo Trento, MD

Sub-Investigator: Mamoo Nakamura, MD

Sub-Investigator: Danny Ramzy, MD

Sub-Investigator: Tarun Chakravarty, MD

Sub-Investigator: Wen Cheng, MD

Sub-Investigator: Moody Makar, MD

Sub-Investigator: Siddharth Singh, MD

St. Joseph Hospital; Recruiting

Orange, California, United States, 92868

Contact: Sandy Chung 714-744-8795 Sandy.Chung@stjoe.org

Principal Investigator: Aidan Raney, MD

Sub-Investigator: Thomas Kim, MD

Sub-Investigator: Taylor Tang, MD

Sub-Investigator: Erum Bajwa, MD

Sub-Investigator: Brian Kolski, MD

Sutter Medical Center-Sacramento; Recruiting

Sacramento, California, United States, 95618

Contact: Michele Guillen 916-781-1613 GuilleM1@sutterhealth.org

Contact: Tammy Donnel 916-887-4651 Donnelt@sutterhealth.org

Principal Investigator: Pei-Hsiu Huang, MD

Sub-Investigator: Michael Ingram, MD

Sub-Investigator: David Roberts, MD

Sub-Investigator: Zi-Jian Xu, MD

Sub-Investigator: Gurpreet Sodhi, MD

Sub-Investigator: Richard Ericson, MD

UC Davis Medical Center; Withdrawn

Sacramento, California, United States, 95817

Scripps Memorial Hospital La Jolla; Recruiting

San Diego, California, United States, 92037

Contact: Misty Daniels 858-824-5249 Daniel.misty@scrippshealth.org

Principal Investigator: Matthew Price, MD

Sub-Investigator: Stephen Romero, MD

Sub-Investigator: Scot Brewster, MD

Sub-Investigator: Sam Baradarian, MD

Sub-Investigator: Ashish Rastogi, MD

Sub-Investigator: Federico De Puy, MD

Sub-Investigator: John Tyner, MD

Sub-Investigator: Ajay Srivastava, MD

Sub-Investigator: Rajeev Mohan, MD

Sub-Investigator: Thomas Heywood, MD

Sub-Investigator: Jessica Funk, MD

Sutter Bay Area; Recruiting

San Francisco, California, United States, 94109

Contact: Milena Ferreira 415-600-5707 FerreiML@sutterhealth.org

Principal Investigator: Christian Spies, MD

Sub-Investigator: Devin Kehl, MD

Sub-Investigator: David Daniels, MD

Sub-Investigator: Mitul Kadakia, MD

Sub-Investigator: James Lai, MD

Sub-Investigator: Brett Sheridan, MD

Sub-Investigator: Conrad Vial, MD

Sub-Investigator: Tomomi Oka, MD

Sub-Investigator: Russel Stanten, MD

Kaiser Permanente San Francisco; Recruiting

San Francisco, California, United States, 94118

Contact: Cristina Casias, RN 415-833-2247 Cristina.Casias@kp.org

Contact: Brenda Le, RN 415-833-2118 Brenda.D.Le@kp.org

Principal Investigator: Andrew Rassi, MD

Sub-Investigator: Jacob Mishell, MD

Sub-Investigator: Vic Melikian, MD

Sub-Investigator: Gordon Leung, MD

Sub-Investigator: Ivy Ku, MD

Sub-Investigator: David Lange, MD

Sub-Investigator: Jonathan Zaroff, MD

Sub-Investigator: Ahmad Sheikh, MD

Stanford University; Recruiting

Stanford, California, United States, 94305

Contact: Tiffany Flores 650-206-3345 Tflores2@stanford.edu

Contact: Tiffany Koyano 650-206-0141 Tkoyano3@standford.edu

Principal Investigator: William Hiesinger, MD

Sub-Investigator: David Lee, MD

Sub-Investigator: Jack Boyd, MD

Sub-Investigator: Rahul Sharma, MD

Sub-Investigator: David Liang, MD

Sub-Investigator: William Fearon, MD

Sub-Investigator: Albert Cheung, MD

Los Robles Hospital and Medical Center; Recruiting

Thousand Oaks, California, United States, 91360

Contact: Mane Arabyan 805-796-3746 Mane.Arabyan@Hcahealthcare.com

Contact: Cherry Papanicolaou 805-368-1803 Cherry.Papanicolaou@Hcahealthcare.com

Principal Investigator: Saibal Kar, MD

Sub-Investigator: David Aliabadi, MD

Sub-Investigator: Philip Faraci, MD

Sub-Investigator: Gregory Fontana, MD

Sub-Investigator: Dustin Lloyd, MD

Sub-Investigator: Andrew Gohbrial, MD

Sub-Investigator: Vishva Dev, MD

Sub-Investigator: Steven Voskanian, MD

United States, Colorado

University of Colorado Hospital; Recruiting

Aurora, Colorado, United States, 80045

Contact: Jackson Haynes 303-724-3938 Jackson.Haynes@cuanschutz.edu

Contact: Tara Churney 720-848-6473 Tara.Churney@cuanschutz.edu

Principal Investigator: John Carroll, MD

Sub-Investigator: Joseph Cleveland, MD

Sub-Investigator: Andreas Brieke, MD

Sub-Investigator: Edward Gill, MD

Sub-Investigator: Robert Quaife, MD

Sub-Investigator: David Fullerton, MD

Sub-Investigator: Aken Desai, MD

Medical Center of the Rockies; Recruiting

Loveland, Colorado, United States, 80538

Contact: Justin Strote, MD 970-221-1000 justin.strote@uchealth.org

Contact: Adam Jaskowiak 970-624-1688 adam.jaskowiak@uchealth.org

Principal Investigator: Mohamad Lazkani, MD

Sub-Investigator: Justin Strote, MD

Sub-Investigator: Mark Douthit, MD

Sub-Investigator: Tristan Dow, MD

Sub-Investigator: C. Patrick Green, MD

Sub-Investigator: Mark Guadagnoli, MD

Sub-Investigator: Satish Chacko, MD

Sub-Investigator: J. Bradley Oldemeyer, MD

Sub-Investigator: Stephen Treat, MD

United States, District of Columbia

Medstar Washington Hospital Center; Recruiting

Washington, District of Columbia, United States, 20010

Contact: Erin Collins 202-877-6622 Erin.c.collins@medstar.net

Principal Investigator: Lowell Satler, MD

Sub-Investigator: Ron Waksman, MD

Sub-Investigator: Istik Ben-dor, MD

Sub-Investigator: Toby Rogers, MD

Sub-Investigator: Preetham Kumar, MD

Sub-Investigator: Patrick Bering, MD

Sub-Investigator: Michael Slack, MD

Sub-Investigator: Mohit Pahuja, MD

United States, Florida

The Cardiac and Vascular Institute Research Foundation; Recruiting

Gainesville, Florida, United States, 32605

Contact: Elizabeth Padgett 352-260-5398 epadgett@tcavi.com

Contact: Abby Foster 352-260-5398 afoster@tcavi.com

Principal Investigator: Charles Klodell, MD

Sub-Investigator: Ilie Barb, MD

Sub-Investigator: Ann Tong, MD

Sub-Investigator: Heather Reed, MD

Sub-Investigator: William Brit-Smith, MD

Sub-Investigator: Aubrey Hall, APRN

Sub-Investigator: Jessica Perry, PA

Sub-Investigator: Angela Rivera, PA

Sub-Investigator: Thomas Zeyl, MD

Sub-Investigator: Kelly Chewning, APRN

Mount Sinai; Recruiting

Miami Beach, Florida, United States, 33140

Contact: Giselle Cortez-Vargas 305-674-2121 ext 56022 Giselle.CortezVargas@msmc.com

Contact: Beatriz Acevedo 305-674-2121 ext 56022 Beatriz.Acevedo@msmc.com

Principal Investigator: Nirat Beohar, MD

Principal Investigator: Steve Xydas, MD

Sub-Investigator: Ivan Arenas, MD

Sub-Investigator: Mark Larralde, MD

Sub-Investigator: Christos Mihos, MD

Sub-Investigator: Esteban Escolar, MD

AdventHealth Orlando; Recruiting

Orlando, Florida, United States, 32803

Contact: Tracey Purvis, RN, CCRC 407-303-9419 tracey.purvis@adventhealth.com

Contact: Sandra Houser, RN, CCRC 407-303-9418 sandra.houser@adventhealth.com

Principal Investigator: Kevin Accola, MD

Sub-Investigator: Jose Arias, MD

Sub-Investigator: Phillip Anderson, MD

Sub-Investigator: Nipun Arora, MD

Cleveland Clinic Florida; Recruiting

Weston, Florida, United States, 33331

Contact: Maria Mejia 954-659-5888 Mejiagm@ccf.org

Contact: Diana Yanez 954-659-5888 Yanezd@ccf.org

Principal Investigator: Emad Hakemi, MD

Sub-Investigator: David Snipelisky, MD

Sub-Investigator: Jose Navia, MD

Sub-Investigator: Craig Asher, MD

United States, Georgia

Piedmont Healthcare; Recruiting

Atlanta, Georgia, United States, 30309

Contact: Shelley Holt 404-605-5003 Shelley.Holt@piedmont.org

Contact: Caryn Bernstein 404-605-5688 Caryn.Bernstein@piedmont.org

Principal Investigator: Pradeep Yadavs, MD

Sub-Investigator: James Kauten, MD

Sub-Investigator: W. Morris Brown, MD

Sub-Investigator: Vinod Thourani, MD

Sub-Investigator: Vivek Rajagopal, MD

Sub-Investigator: Christopher Meduri, MD

Sub-Investigator: Benjamin DeMoss, MD

Sub-Investigator: Peter Flueckiger, MD

Sub-Investigator: Sara Mobasseri, MD

Sub-Investigator: Venkateshwar Polsani, MD

Sub-Investigator: Hassan Sayegh, MD

Sub-Investigator: Mani Vannan, MD

Sub-Investigator: Vibhav Rangarajan, MD

Sub-Investigator: Roshin Mathew, MD

Sub-Investigator: Ramona Davis, PA

Sub-Investigator: Amy Simone, PA

Emory University Hospital and Emory University Hospital Midtown; Recruiting

Atlanta, Georgia, United States, 30322

Contact: Elizabeth Charles 404-686-1249 Elizabeth.z.charles@emory.edu

Contact: Kristy Pitts 404-686-5775 klpitts@emory.edu

Principal Investigator: Adam Greenbaum, MD

Sub-Investigator: Vasilis Babaliaros, MD

Sub-Investigator: Kendra Grubb, MD

Sub-Investigator: Patrick Gleason, MD

Sub-Investigator: Chandan Deveriddy, MD

United States, Illinois

Northwestern University; Recruiting

Chicago, Illinois, United States, 60611

Contact: BCVI Clinical Trials Unit 312-926-4000 heartresearch@northwestern.edu

Principal Investigator: Charles Davidson, MD

Sub-Investigator: S. Chris Malaisrie, MD

Sub-Investigator: Duc Thinh Pham, MD

Sub-Investigator: Andrei Churyla, MD

Sub-Investigator: James Thomas, MD

Sub-Investigator: Jyothy Puthumana, MD

Sub-Investigator: Akhil Narang, MD

Sub-Investigator: James Flaherty, MD

Sub-Investigator: R. Kannan Mutharasan, MD

Sub-Investigator: Ranya Sweis, MD

Advocate Health & Hospitals Corp/Edward Heart Hospital; Withdrawn

Naperville, Illinois, United States, 60540

United States, Indiana

St. Vincent Heart Center; Recruiting

Indianapolis, Indiana, United States, 46290

Contact: Mary Lynn Burkert 317-583-6116 Mary.burkert@ascension.org

Contact: Jana Fisher 317-583-7804 Jana.fisher@ascension.org

Principal Investigator: James B Hermiller, MD

Sub-Investigator: Andrew Sampson, MD

Sub-Investigator: Sina Moainie, MD

Sub-Investigator: David Heimansohn, MD

United States, Iowa

University of Iowa Hospitals & Clinics; Recruiting

Iowa City, Iowa, United States, 52242

Contact: Amy Ollinger, RN 319-353-6675 Amy-Ollinger@uiowa.edu

Contact: Sidakpal Panaich, MD 319-384-5752 Sidakpal-panaich@uiowa.edu

Principal Investigator: Phillip A Horwitz, MD

Sub-Investigator: James D Rossen, MD

Sub-Investigator: Linda Cadaret, MD

Sub-Investigator: Ernesto Ruiz Duque, MD

Sub-Investigator: Ramzi El Accaoui, MD

Sub-Investigator: Mohammad Bashir, MD

Sub-Investigator: Anthony Panos, MD

Sub-Investigator: Kimberly Staffey, MD

United States, Kansas

Cardiovascular Research Institute of Kansas; Withdrawn

Wichita, Kansas, United States, 67226

United States, Louisiana

Oschner Medical Center; Recruiting

New Orleans, Louisiana, United States, 70121

Contact: Cherie Abadie 504-842-5071 Cabadie@Ochsner.org

Contact: Barbara Hirsitus 504-842-4833 Bhirsitus@oschner.org

Principal Investigator: Stephen Jenkins, MD

Sub-Investigator: Stephen Ramee, MD

Sub-Investigator: Clement Eiswirth, MD

Sub-Investigator: Stephen Spindel, MD

Sub-Investigator: Selim Krim, MD

Sub-Investigator: Hamang Patel, MD

Sub-Investigator: Hector Ventura, MD

Sub-Investigator: Patrick Parrino, MD

Sub-Investigator: Stacy Mandras, MD

United States, Massachusetts

Massachusetts General Hospital; Recruiting

Boston, Massachusetts, United States, 02114

Contact: Lina Fu 617-643-1371 Lfu2@partners.org

Contact: Matthew Covello 617-643-1371 Mcovello@partners.org

Principal Investigator: Ignacio Inglessis-Azuaje, MD

Sub-Investigator: Sammy Elmariah, MD

Sub-Investigator: Rahul Sakhuja, MD

Sub-Investigator: Igor Palacios, MD

Sub-Investigator: Arminder Jassar, MD

Sub-Investigator: Nathaniel Langer, MD

Sub-Investigator: Jonathan Passeri, MD

Sub-Investigator: Jacob Dal-Bianco, MD

Sub-Investigator: Evin Yucel, MD

Sub-Investigator: Gregory Lewis, MD

Sub-Investigator: William Carlson, MD

Sub-Investigator: Erin Coglianese, MD

Sub-Investigator: Sunu Thomas, MD

Sub-Investigator: Nasrien Ibrahim, MD

Brigham and Woman's Hospital; Recruiting

Boston, Massachusetts, United States, 02115

Contact: Lisa Downey 617-732-4812 Ldowney2@bwh.harvard.edu

Contact: Brittany Bauman 1-617-525-7072 Bbauman1@bwh.hardvard.edu

Principal Investigator: Pinak Shah, MD

Sub-Investigator: Alice Kim, MD

Sub-Investigator: Ashraf Sabe, MD

Sub-Investigator: Piotr Sobieszczyk, MD

Sub-Investigator: Garrick Stewart, MD

Beth Israel Deaconess Medical Center; Recruiting

Boston, Massachusetts, United States, 02215

Contact: Jennifer Kaufman, RN, MS 617-632-8956 jmkaufma@bidmc.harvard.edu

Contact: Patricia Tyler, BA 617-632-7727 Ptyler@bidmc.harvard.edu

Principal Investigator: Roger Laham, MD

Sub-Investigator: Kamal Khabbaz, MD

Sub-Investigator: David C Lui, MD

Sub-Investigator: Senthil Nathan, MD

Sub-Investigator: Louis Chu, MD

Sub-Investigator: Eli Gelfand, MD

Sub-Investigator: Duane Pinto, MD

Sub-Investigator: James Chang, MD

Sub-Investigator: Marie France Poulin, MD

Sub-Investigator: Feroze Mahmood, MD

Sub-Investigator: Edward Grandin, MD

Sub-Investigator: Wally Omar, MD

Sub-Investigator: Sankalp Sehgal, MD

Sub-Investigator: Marwa Sabe, MD

United States, Michigan

University of Michigan; Recruiting

Ann Arbor, Michigan, United States, 48109

Contact: Jessica Oakley 734-232-9051 joakley@med.umich.edu

Principal Investigator: Stanley Chetcuti, MD

Sub-Investigator: Steven Bolling, MD

Sub-Investigator: Daniel Menees, MD

Sub-Investigator: Matthew Romano, MD

Sub-Investigator: Neal Duggal, MD

Sub-Investigator: Abbas Bitar, MD

Sub-Investigator: Troy LaBounty, MD

Henry Ford Hospital; Recruiting

Detroit, Michigan, United States, 48202

Contact: Ardit Kacorri 313-916-7452 Akacorr1@hfhs.org

Contact: Samantha Henry 313-916-4475 SHenry@hfhs.org

Principal Investigator: William O'Neill, MD

Sub-Investigator: Marvin Eng, MD

Sub-Investigator: Tiberio Frisoli, MD

Sub-Investigator: Dee Dee Wang, MD

Sub-Investigator: James Lee, MD

Sub-Investigator: Hassan Nemeh, MD

Sub-Investigator: Raed Alnajjar, MD

United States, Minnesota

Fairview Health Services; Withdrawn

Maplewood, Minnesota, United States, 55109

Mayo Clinic; Recruiting

Rochester, Minnesota, United States, 55902

Contact: Amanda Biddle, RN 507-255-6133 Biddle.Amanda@mayo.edu

Contact: Craig Konwinski 507-255-6133 Konwinski.Craig@mayo.edu

Principal Investigator: Mayra Guerrero, MD

Sub-Investigator: Guy Reeder, MD

Sub-Investigator: Charanjit Rihal, MD

Sub-Investigator: Ratnasari Padang, MD

Sub-Investigator: Juan Crestanello, MD

Principal Investigator: Mackram Eleid, MD

United States, Missouri

St.Luke's Hospital of Kansas City; Recruiting

Kansas City, Missouri, United States, 64111

Contact: Alicia Roberts, RN 816-932-5987 aroberts@saint-lukes.org

Contact: Sheila Erwin, RN 816-932-7996 serwin@saint-lukes.org

Principal Investigator: Adnan Chhatriwalla, MD

Sub-Investigator: Keith Allen, MD

Sub-Investigator: David Skolnick, MD

Sub-Investigator: V. Erick Thompson, MD

Sub-Investigator: Bethany Austin, MD

Sub-Investigator: John Saxon, MD

Sub-Investigator: Kenneth Huber, MD

Sub-Investigator: Anthony Magalski, MD

Sub-Investigator: Michael Main, MD

Sub-Investigator: A. Michael Borkon, MD

Sub-Investigator: J. Russell Davis, MD

Washington University/Barnes Jewish Hospital; Recruiting

Saint Louis, Missouri, United States, 63110

Contact: Kyle Stumbaugh 314-747-0707 Kyles@wustl.edu

Contact: Kimberly Striler 314-747-4452 KStriler@wustl.edu

Principal Investigator: Puja Kachroo, MD

Principal Investigator: Alan Zajarias, MD

Sub-Investigator: Majesh Makan, MD

Sub-Investigator: Harold Roberts, MD

Sub-Investigator: John Lasala, MD

Sub-Investigator: Marc Sintek, MD

Sub-Investigator: Tsuyoshi Kaneko, MD

Sub-Investigator: Nishath Quader, MD

United States, New Jersey

Morristown Medical Center; Recruiting

Morristown, New Jersey, United States, 07960

Contact: Catherine Van Zile, RN 973-971-5951 Catherine.vanzile@atlantichealth.org

Principal Investigator: Robert Kipperman, MD

Sub-Investigator: Philippe Genereux, MD

Sub-Investigator: John Brown, MD

Sub-Investigator: Konstantinos Koulogiannis, MD

Sub-Investigator: James Slater, MD

Sub-Investigator: Christopher Magovern, MD

Sub-Investigator: Bledi Zaku, MD

Rutgers-RWJMS; Recruiting

New Brunswick, New Jersey, United States, 08901

Contact: Jennifer Pineda-Salazar 732-235-9125 JP1838@rwjms.rutgers.edu

Contact: Meghan Smith 732-235-9228 meghan.smith@rutgers.edu

Principal Investigator: Mark Russo, MD

Sub-Investigator: Leonard Lee, MD

Sub-Investigator: Abdul Hakeem, MD

Sub-Investigator: Bruce Haik, MD

Sub-Investigator: Deepa Iyer, MD

Sub-Investigator: Sabha Bhatti, MD

United States, New York

Albany Medical College; Recruiting

Albany, New York, United States, 12208

Contact: Brenda Romero 518-262-8579 Romerob@amc.edu

Contact: Amanda O'Malley 518-262-6077 Aomalley@capitalcardiology.com

Principal Investigator: Chanderdeep Singh, MD

Sub-Investigator: Augustin Delago, MD

Sub-Investigator: Mohammad El-Hajjar, MD

Sub-Investigator: Eugene Pashkovetsky, MD

Sub-Investigator: Lance Sullenberger, MD

Montefiore Medical Center; Recruiting

Bronx, New York, United States, 10461

Contact: Zeynep Alimchandani 718-920-5633 Zalimchand@montefiore.org

Contact: Veronica Day 718-904-2172 Vday@montefiore.org

Principal Investigator: Mohammed Latib, MD

Sub-Investigator: Mei Chau, MD

Sub-Investigator: Courtney Lucyk, RN

Sub-Investigator: Mary Meneses, RN

Sub-Investigator: Sandhya Murthy, MD

Sub-Investigator: Patricia Chevez, MD

State University of New York at Buffalo; Recruiting

Buffalo, New York, United States, 14203

Contact: Courtney Bishop 716-888-4839 Cabishop@buffalo.edu

Contact: Robin Stein, RN 716-888-4859 rmstein3@buffalo.edu

Principal Investigator: Vijay Iyer, MD

Sub-Investigator: Stanley Fernandez, MD

NYU Winthrop Hospital; Recruiting

Mineola, New York, United States, 11501

Contact: Melissa Batteria 516-663-9738 Melissa.Batteria@nyulangone.org

Contact: Marina Licata 516-663-9738 Marina.licata@nyulangone.org

Principal Investigator: Richard Schwartz, DO

Sub-Investigator: Khaled Salhab, MD

Sub-Investigator: Nicholas Raio, MD

Sub-Investigator: Daniel Donohue, MD

Sub-Investigator: George Gubernikoff, MD

Sub-Investigator: Richard Jacaruso, MD

NYU Langone Health; Recruiting

New York, New York, United States, 10016

Contact: Samantha Lo 808-724-8971 samantha.lo@nyulangone.org

Contact: Liora Rafailova 212-263-0098 Liora.Rafailova@nyulangone.org

Principal Investigator: Mathew Williams, MD

Sub-Investigator: Cezar Staniloae, MD

Sub-Investigator: Homam Ibrahim, MD

Sub-Investigator: Michael Querijero, MD

Sub-Investigator: Alan Vainrib, MD

Sub-Investigator: Shailine Rao, MD

Columbia University Medical Center/New York Presbyterian Hospital; Recruiting

New York, New York, United States, 10032

Contact: Kate Dalton 347-514-3366 Keb2114@cumc.columbia.edu

Contact: Lauren Privitera 347-271-0901 Lp2183@cumc.columbia.edu

Principal Investigator: Susheel Kodali

Sub-Investigator: Tamim Nazif

Sub-Investigator: Isaac George

Sub-Investigator: Vinayak Bapat

Sub-Investigator: Torsten Vahl

Sub-Investigator: Vivian Ng

Sub-Investigator: Rebecca Hahn

Sub-Investigator: Amisha Patel

Sub-Investigator: Omar Khalique

Lenox Hill Hospital and North Shore University; Recruiting

New York, New York, United States, 10075

Contact: Anthony Kaywood 516-562-2345 akaywood1@northwell.edu

Contact: Ame Ng 212-434-4916 ang13@northwell.edu

Principal Investigator: Chad A Kliger, MD

Sub-Investigator: S. Jacob Scheinerman, MD

Sub-Investigator: Nirav C Patel, MD

Sub-Investigator: Luigi Pirelli, MD

Sub-Investigator: Bruce Rutkin, MD

Sub-Investigator: Elana Koss, MD

Sub-Investigator: Gerin Stevens, MD

Sub-Investigator: Craig Basman, MD

Sub-Investigator: Derek Brinster, MD

Sub-Investigator: Samit Shah, MD

Sub-Investigator: Jacinda Berg, MD

Sub-Investigator: Eric Drobinko, MD

Sub-Investigator: Gregory Maurer, MD

Sub-Investigator: Sheel Vatsia, MD

Sub-Investigator: Shirish Vullaganti, MD

Sub-Investigator: Sean Wilson, MD

Sub-Investigator: Pey-Jen Yu, MD

Sub-Investigator: Lauren Cooper, MD

Sub-Investigator: James Taylor, MD

Rochester General Hospital; Recruiting

Rochester, New York, United States, 14621

Contact: Jennifer LaLonde 585-922-3536 Jennifer.Lalonde@RochesterRegional.org

Contact: Emily Pierce 585-922-4523 emily.pierce2@rochestergeneral.org

Principal Investigator: Jeremiah Depta, MD

Sub-Investigator: Bipul Baibhav, MD

Sub-Investigator: Konstantine Tzimas, MD

Sub-Investigator: Vishal Parikh, MD

Sub-Investigator: Deyanira Prastein, MD

Sub-Investigator: David Corteville, MD

St. Francis Hospital; Recruiting

Roslyn, New York, United States, 11576

Contact: Lyn Santiago, RN 516-562-6763 Lyn.santiago@chsli.org

Contact: Linda Bongiovanni, RN 516-562-6790 Linda.bongiovanni@chsli.org

Principal Investigator: George A Petrossian, MD

Principal Investigator: Newell B Robinson, MD

Sub-Investigator: Andrew D Berke, MD

Sub-Investigator: William Chung, MD

Sub-Investigator: Lin Wang, MD

United States, North Carolina

Atrium Health/Sanger Heart & Vascular Institute; Active, not recruiting

Charlotte, North Carolina, United States, 28203

United States, Ohio

The Christ Hospital; Recruiting

Cincinnati, Ohio, United States, 45219-2906

Contact: Monica Treta 513-585-1707 Monica.Treta@thechristhospital.com

Principal Investigator: Joseph Choo, MD

Principal Investigator: Mario Castillo-Sang, MD

Sub-Investigator: Sayta Shreenivas, MD

Sub-Investigator: Terri Stewart-Dehner, MD

Cleveland Clinic Foundation; Recruiting

Cleveland, Ohio, United States, 44195

Contact: Lydia Sweeney 216-444-7754 sweenel@ccf.org

Contact: Nora Brown 216-445-8063 Brownn2@ccf.org

Principal Investigator: Samir Kapadia, MD

Sub-Investigator: Leonard Rodriguez, MD

Sub-Investigator: James Yun, MD

Sub-Investigator: Rhonda Miyasaka, MD

Sub-Investigator: Serge Harb, MD

Sub-Investigator: Amar Krishnaswamy, MD

The Ohio State University Medical Center; Recruiting

Columbus, Ohio, United States, 43210

Contact: Annie Kellum 614-366-8848 annie.kellum@osu.edu

Principal Investigator: Konstantinos Boudoulas, MD

Sub-Investigator: Scott Lily, MD

Sub-Investigator: Gregory Rushing, MD

Sub-Investigator: David Orsinelli, MD

Sub-Investigator: Thura Harfi, MD

Sub-Investigator: Susan O'Neil, MD

OhioHealth Research Institute; Recruiting

Columbus, Ohio, United States, 43214

Contact: Katy Monnin 614-566-1250 Katy.Monnin@Ohiohealth.com

Contact: Wachy Vongchucherd 614-788-3861 Wachy.Vongchucherd@ohiohealth.com

Principal Investigator: Carlos Sanchez, MD

Principal Investigator: Nathan Howard Kander, MD

Sub-Investigator: Arash Arshi, MD

Sub-Investigator: Steven Yakubov, MD

Sub-Investigator: Steven Duff, MD

Sub-Investigator: Naveen Saha, MD

Sub-Investigator: David Richards, MD

United States, Oklahoma

Integris Health Baptist Medical Center; Recruiting

Oklahoma City, Oklahoma, United States, 73112

Contact: Bethany Fife 405-951-8607 Bethany.fife@integrisok.com

Contact: Melissa Adams 405-949-4029 Melissa.adams2@integrisok.com

Principal Investigator: Jeffrey Sparling, MD

Sub-Investigator: Jon Blaschke, MD

Sub-Investigator: George Chrysant, MD

Sub-Investigator: Douglas Horstmanshof, MD

Sub-Investigator: David Vanhooser, MD

Oklahoma Cardiovascular; Recruiting

Oklahoma City, Oklahoma, United States, 73120

Contact: Donna Grossman 405-608-1272 Dgrossman@okheart.com

Contact: Stacie Hanes 405-608-1272 Shanes@okheart.com

Principal Investigator: Mohammad Ghani, MD

Sub-Investigator: John Williams, MD

Sub-Investigator: Mark Bodenhamer, MD

Sub-Investigator: Pamela Craven, MD

Sub-Investigator: Jeffery Garrett, MD

Sub-Investigator: Varun Khanna, MD

Sub-Investigator: Nicole Tran, MD

Oklahoma Heart Institute; Recruiting

Tulsa, Oklahoma, United States, 74104

Contact: Donnell Smith 918-579-4939 Donnell.smith@oklahomaheart.com

Contact: Angela Sconyers 918-579-4924

Principal Investigator: Kamran Muhammad, MD

Sub-Investigator: Wayne Leimbach, MD

Sub-Investigator: Hoda Butrous, MD

Sub-Investigator: John Tulloch, MD

Sub-Investigator: Michael Phillips, MD

Sub-Investigator: Georgianne Tokarchik, APRN-CNS

United States, Oregon

Providence St. Vincent Medical Center; Withdrawn

Portland, Oregon, United States, 97225

Oregon Health & Science University; Recruiting

Portland, Oregon, United States, 97239

Contact: Taylor Toro 503-494-3491 Torot@OHSU.edu

Principal Investigator: Firas Zahr, MD

Sub-Investigator: Howard Song, MD, PhD

Sub-Investigator: Scott Chadderdon, MD

Sub-Investigator: Harsh Golwala, MD

Sub-Investigator: Richelle Wildey, MD

United States, Pennsylvania

Hospital of the University of Pennsylvania/Penn Presbyterian Medical Center; Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contact: Kelli Cook 215-459-4478 Kelli.cook@pennmedicine.upenn.edu

Contact: Karen Maslowski 215-662-9019 Karen.Maslowski@pennmedicine.upenn.edu

Principal Investigator: Howard Herrmann, MD

Principal Investigator: Wilson Szeto, MD

Sub-Investigator: Gene Chang, MD

Sub-Investigator: Hansie Methelier, MD

Sub-Investigator: Jignesh Bhavsar, MD

Sub-Investigator: Juan Ortega Legaspi, MD

Sub-Investigator: Frank Silvestry, MD

Allegheny General Hospital; Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contact: Stephanie Vehec 412-359-6908 Stephanie.Vehec@ahn.org

Contact: Tracy Spirk 412-359-4025 Tracy.Spirk@ahn.org

Principal Investigator: Walter McGregor, MD

Sub-Investigator: Mithun Chakravarthy, MD

Sub-Investigator: David Lasorda, MD

Sub-Investigator: Stephen Bailey, MD

Sub-Investigator: Victor Farah, MD

Sub-Investigator: Matthew Lander, MD

Sub-Investigator: Rachel Hughes-Doichev, MD

Pinnacle Health Cardiovascular Institute/ UPMC Pinnacle Harrisburg; Recruiting

Wormleysburg, Pennsylvania, United States, 17043

Contact: Courtney Rodgers, RN 717-639-6410 clrodgers@pinnaclehealth.org

Contact: Brittany Fehr 717-503-5671 bfehr@pinnaclehealth.org

Principal Investigator: Mubashir Mumtaz, MD

Sub-Investigator: Hemal Gada, MD

Sub-Investigator: Amit Vora, MD

Sub-Investigator: David Loran, MD

Sub-Investigator: Nikhil Jaik, MD

Sub-Investigator: Atizazul Mansoor, MD

Sub-Investigator: Roberto Hodara, MD

Lankenau Medical Center; Recruiting

Wynnewood, Pennsylvania, United States, 19096

Contact: Sherry McDermott 610-312-1153 Mcdermotts@mlhs.org

Principal Investigator: Scott Goldman, MD

Sub-Investigator: William Gray, MD

Sub-Investigator: Roberto Rodriguez, MD

Sub-Investigator: Paul Coady, MD

Sub-Investigator: Sandra Abramson, MD

Sub-Investigator: Katie Hawthorne, MD

United States, Tennessee

Centennial Medical Center; Recruiting

Nashville, Tennessee, United States, 37203

Contact: Abdullah Shamsuddin 615-329-7274 Abdullah.shamsuddin@saracannon.com

Contact: Hallie Hank 615-329-6856 Hallie.hank@hcahealthcare.com

Principal Investigator: John Riddick, MD

Sub-Investigator: Sreekumar Subramanian, MD

Sub-Investigator: Thomas McRae, MD

Sub-Investigator: Thomas Johnston, MD

Sub-Investigator: David Huneycutt, MD

Sub-Investigator: Samuel Horr, MD

Sub-Investigator: Andrew Goodman, MD

Sub-Investigator: Parag Patel, MD

Saint Thomas Heart at Saint Thomas West; Recruiting

Nashville, Tennessee, United States, 37205

Contact: Amelia Drennan 615-222-3815 Amelia.drennan@ascension.org

Contact: Hollie Horton 615-222-3865 Hollie.horton@ascension.org

Principal Investigator: Michael A Morse, MD

Sub-Investigator: Evelio Rodriguez, MD

Sub-Investigator: Wilson E Kemp, MD

Sub-Investigator: John B Biglane, MD

Sub-Investigator: Andrew Zurick, MD

Sub-Investigator: Sasan Raissi, MD

Vanderbilt University Medical Center; Recruiting

Nashville, Tennessee, United States, 37232

Contact: Natalie Jackson 615-343-1782 Natalie.Jackson@VUMC.org

Contact: Crystal Emerson 615-936-9918 Crystal.Emerson@VUMC.org

Principal Investigator: Colin Barker, MD

Principal Investigator: Brian Lindman, MD

Sub-Investigator: Kashish Goel, MD

Sub-Investigator: Holly Gonzales, MD

Sub-Investigator: Michael Baker, MD

Sub-Investigator: Kelly Schlendorf, MD

Sub-Investigator: Mias Pretorius, MD

United States, Texas

Medical City Dallas; Withdrawn

Dallas, Texas, United States, 75230

HCA Houston Healthcare Medical Center; Recruiting

Houston, Texas, United States, 77004

Contact: Joan Morrison 832-633-5463 Joan.Morrison@HCAhealthcare.com

Contact: Faisal Cheema 917-499-5115 Faisal.Cheema@HCAhealthcare.com

Principal Investigator: Pranav Loyalka, MD

Sub-Investigator: Abdul Hannan-Chaugle, MD

Sub-Investigator: Carlos Encarnacion, MD

Sub-Investigator: Eyal Porat, MD

Sub-Investigator: Stephanie Coulter, MD

Sub-Investigator: Amir Gahremanpour, MD

Baylor College of Medicine; Recruiting

Houston, Texas, United States, 77030

Contact: Rene Plascencia 713-798-6027 Rene.Plascencia@bcm.edu

Contact: Stephen Harold 713-798-6510

Principal Investigator: Srikanth Koneru, MD

Sub-Investigator: Kenneth Liao, MD

Sub-Investigator: Guilherme Silva, MD

Sub-Investigator: Leo Simpson, MD

Houston Methodist Hospital; Recruiting

Houston, Texas, United States, 77030

Contact: Lisa Green, RN 713-441-3629 LMGreen@houstonmethodist.org

Contact: LaShawna Green, RN 713-441-6548 LaGreen@houstonmethodist.org

Principal Investigator: Neal Kleiman, MD

Principal Investigator: Michael Reardon, MD

Sub-Investigator: Nadeen Faza, MD

Sub-Investigator: Apurva Patel, MD

Sub-Investigator: Manuel Reyes, MD

Sub-Investigator: Marvin Atkins, MD

The University of Texas Health Science Center at Houston; Recruiting

Houston, Texas, United States, 77030

Contact: Elena Viverette 713-500-5214 Elena.a.viverette@uth.tmc.edu

Contact: Elizabeth Turrentine 713-500-5683 Elizabeth.p.turrentine@Uth.tmc.edu

Principal Investigator: Abhijeet Dhoble, MD

Sub-Investigator: Richard W Smalling, MD, PhD

Sub-Investigator: Enrique Garcia-Sayan, MD

Sub-Investigator: Anthony Estrera, MD

The Heart Hospital Baylor Plano; Recruiting

Plano, Texas, United States, 75093

Contact: Gabriella Velder 469-814-4732 Gabriella.velder@bswhealth.org

Contact: Megan Lamacki 469-814-4854 Megan.Lamacki@bswhealth.org

Principal Investigator: Robert L Smith, MD

Sub-Investigator: Molly Szerlip, MD

Sub-Investigator: Paul Grayburn, MD

Sub-Investigator: Timothy George, MD

Sub-Investigator: Sameh Sayfo, MD

United States, Utah

Intermountain Medical Center; Recruiting

Salt Lake City, Utah, United States, 84107

Contact: Brittany Hayes 801-507-4925 Brittany.Hayes@imail.org

Contact: Adrianna Robison 801-507-4764 Adrianna.Robison@imail.org

Principal Investigator: Brian K Whisenant, MD

Sub-Investigator: James Harkness, MD

Sub-Investigator: Kent Jones, MD

Sub-Investigator: Stephen Clayson, MD

United States, Virginia

University of Virginia; Recruiting

Charlottesville, Virginia, United States, 22908

Contact: Linda Bailes, RN, CCRC 434-982-1058 lgs2m@virginia.edu

Principal Investigator: David Scott Lim, MD

Sub-Investigator: James Bergin, MD

Sub-Investigator: John Kern, MD

Sub-Investigator: Michael Ragosta, MD

Sub-Investigator: Leora Yarboro, MD

Sub-Investigator: Kenan Yount, MD

Sentara Norfolk General Hospital; Recruiting

Norfolk, Virginia, United States, 23507

Contact: Tina Calayo 757-880-6883 Cacalayo@sentara.com

Contact: Camille Richards 757-388-5480 SCRI@sentara.com

Principal Investigator: Paul Mahoney, MD

Sub-Investigator: David Adler, MD

Sub-Investigator: Joseph Newton, MD

Chippenham Johnston & Willis Medical Center; Recruiting

Richmond, Virginia, United States, 23225

Contact: Marian Coley 804-833-9761 Marian.coiley@hcahealthcare.com

Contact: Stephanie Burton 804-572-2747 Stephanie.burton@hcahealth.com

Principal Investigator: David Scott Lim, MD

Sub-Investigator: Matthew Chung, MD

Sub-Investigator: Chiowan Hahn, MD

Sub-Investigator: Robert Levitt, MD

Sub-Investigator: John Trevor Posenau, MD

Sub-Investigator: Tim Rohman, MD

Sub-Investigator: Ramesh Kundur, MD

Sub-Investigator: James Garnett, MD

United States, Washington

Swedish Medical Center; Recruiting

Seattle, Washington, United States, 98122

Contact: Michelle Poitevin 206-320-2385 Michelle.Poitevin@swedish.org

Contact: Andrea Drouhard 206-215-3982 Andrea.Drouhard@swedish.org

Principal Investigator: Sameer Gafoor, MD

Sub-Investigator: Sameer Gafoor, MD

Sub-Investigator: John Petersen, MD

Sub-Investigator: Oana Petrescu, MD

Sub-Investigator: Patrick Ryan, MD

Sub-Investigator: Eric Lehr, MD

University of Washington; Recruiting

Seattle, Washington, United States, 98195

Contact: John Tushinski 206-685-4346 Jtushin@uw.edu

Sub-Investigator: Gabriel Aldea, MD

Sub-Investigator: Georg Mackensen, MD

Principal Investigator: James McCabe, MD

United States, Wisconsin

Aurora St. Luke's Medical Center; Recruiting

Milwaukee, Wisconsin, United States, 53215

Contact: Dena Burke, RN 414-649-3490 Dena.burke@aah.org

Contact: Deborah Waller, RN 414-649-3439 Deborah.waller@aah.org

Principal Investigator: Suhail Allaqaband, MD

Sub-Investigator: Eric Weiss, MD

Sub-Investigator: Renuka Jain, MD

Sub-Investigator: Nasir Sulemanjee, MD

Sub-Investigator: Daniel Harland, MD

Sub-Investigator: Tanvir Bajwa, MD

Canada, British Columbia

St. Pauls Hospital; Recruiting

Vancouver, British Columbia, Canada, V6E 1M7

Contact: Tanja Kot +1-604-682-2344 ext 64982 TKot@Providencehealthcare.bc.ca

Contact: Lenka Antoni +1-604-806-8804 Lenka.Antoni@Providencehealthcare.bc.ca

Principal Investigator: Robert Boone, MD

Principal Investigator: John Webb, MD

Sub-Investigator: Mustafa Toma, MD

Sub-Investigator: Jian Ye, MD

Sub-Investigator: Robert Moss, MD

Canada, Ontario

St. Michael's Hospital; Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contact: Alana Harrington 416-864-6060 ext 49003 Alana.Harrinton@Unityhealth.to

Contact: Ivana Kandic 416-864-6060 ext 49003 Ivana.Kandic@unityhealth.to

Principal Investigator: Neil Fam, MD

Sub-Investigator: Gordon Moe, MD

Sub-Investigator: Geraldine Ong, MD

Sub-Investigator: Kim Connelly, MD

Sub-Investigator: Jeremy Edwards, MD

Sub-Investigator: Askhay Bagai, MD

Sub-Investigator: Mark Peterson, MD

Canada

Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ) ULaval; Recruiting

Québec, Canada, G1V 4G5

Contact: Shirley Baril 418-656-8711 ext 4129 Shirley.baril@criucpq.ulaval.ca

Contact: Dominique LaChance 418-656-8711 ext 3055 Dominique.Lachance@criucpq.ulaval.ca

Principal Investigator: Josep Rodés-Cabau, MD

Sub-Investigator: Kim O'Connor, MD

Sub-Investigator: Jonathan Beaudoin, MD

Sub-Investigator: Mathieu Bernier, MD

Sub-Investigator: Francois Dagenais, MD

Sub-Investigator: Eric Dumont, MD

Sub-Investigator: Jean-Michel Paradis, MD

Sub-Investigator: Alberto Alperi-Garcia, MD

Sub-Investigator: Erwan Salaun, MD

Germany

Klinik für Allgemeine und Interventionelle Kardiologie/Angiologie, Herz- und Diabeteszentrum NRW, Universitätsklinik der Ruhr-Universität Bochum; Recruiting

Bad Oeynhausen, Germany, 32545

Contact: Elisabeth Winkelmann +49(0) 5731/97-3758 ewinkelmann@hdz-nrw.de

Contact: Kerstin Freese +49(0) 5731-973397 kfreese@hdz-nrw.de

Principal Investigator: Volker Rudolph, MD

Sub-Investigator: Kai Friedrichs, MD

Sub-Investigator: Werner Scholtz, MD

Sub-Investigator: Tanja Rudolph, MD

Sub-Investigator: Sabine Bleiziffer, MD

Sub-Investigator: Rene Schramm, MD

Sub-Investigator: Kavous Hakim-Meibodi, MD

Sub-Investigator: Tomasz Gilis-Januszewski, MD

Sub-Investigator: Nobuyuki Furukawa, MD

Sub-Investigator: Muhammed Gercek, MD

Sub-Investigator: Arseniy Goncharov, MD

Sub-Investigator: Max Potratz, MD

Sub-Investigator: Hazem Omran, MD

Sub-Investigator: Maria Ivannikova, MD

Herzzentrum Universitätsklinikum Koln; Recruiting

Cologne, Germany, 50937

Contact: Iris Berg +49 221 478 4191 Iris.berg@uk-koeln.de

Contact: Ana Heinrichs +49 221 478 32417 Ana.heinrichs@uk-koeln.de

Principal Investigator: Stephan Baldus, MD

Sub-Investigator: Roman Pfister, MD

Sub-Investigator: Marcel Halbach, MD

Sub-Investigator: Elmar Kuhn, MD

Sub-Investigator: Christos Iliadis, MD

Sub-Investigator: Henrik ten Freyhaus, MD

Sub-Investigator: Monique Bruwer, MD

Sub-Investigator: Jennifer Maryam von Stein, MD

Herrzentrum Dresden GmbH Universitätklinik an der Technischen Universität Dresden; Recruiting

Dresden, Germany, 01307

Contact: Jennifer Hommel (Adam) +49 351 450 25237 jennifer.hommel@tu-dresden.de

Contact: Marion Mai +49 351 450 25 261 marion.mai@tu-dresden.de

Principal Investigator: Axel Linke, MD

Sub-Investigator: Stephen Haussig, MD

Sub-Investigator: Norman Mangner, MD

Sub-Investigator: Felix Heidrich, MD

Sub-Investigator: Krunoslav M Sveric, MD

Sub-Investigator: Goerg Ende, MD

Sub-Investigator: Ephraim Winzer, MD

Sub-Investigator: Utz Kappert, MD

Sub-Investigator: Konstantinos Alexiou, MD

Sub-Investigator: Nora Rochor, MD

Universitätsklinikum Essen (AöR) Klinik für Kardiologie und Angiologie am Westdeutschen Herz- und Gefäßzentrum; Recruiting

Essen, Germany, 45147

Contact: Alexander Weise +49 201 723 84833 alexander.wiese@uk-essen.de

Contact: Olga Babinets +49 201 723 84834 olga.babinets@uk-essen.de

Principal Investigator: Peter Ludike, MD

Sub-Investigator: Tienush Rassaf, MD

Sub-Investigator: Alexander Weymann, MD

Sub-Investigator: Alexander Lind, MD

Sub-Investigator: Bastian Schmack, MD

Sub-Investigator: Matthias Riebisch, MD

Sub-Investigator: Stefanie Hendricks, MD

Sub-Investigator: Lars Michel, MD

Sub-Investigator: Amir-Abbas Mahabadi, MD

Universitätsklinikum Gießen Medizinische Klinik I, Innere Medizin/ Kardiologie; Recruiting

Gießen, Germany, 35392

Contact: Christiane Kelm +49 641 985 57941 Christiane.Kelm@innere.med.uni-giessen.de

Contact: Anne Staubitz +49 641 985 57941 Anne.Staubitz@innere.med.uni-giessen.de

Principal Investigator: Holger Nef, MD

Sub-Investigator: Niklas Boeder, MD

Sub-Investigator: Matthias Bayer, MD

Sub-Investigator: Birgit Assmus, MD

Sub-Investigator: Peter Roth, MD

Sub-Investigator: Stanislav Keranov, MD

Sub-Investigator: Korinna Feldmann, MD

Sub-Investigator: Florian Blachutzik, MD

Universitäres Herzzentrum Hamburg GmbH (UHZ) Klinik und Poliklinik für Allgemeneine und Interventionelle Kardiologie; Recruiting

Hamburg, Germany, 20246

Contact: Kirsten Suhr +49 40-741056287 K.suhr@uke.de

Contact: Sonja Stolze +49 40 7410 53246 S.stolze@uke.de

Principal Investigator: Niklas Schofer, MD

Sub-Investigator: Daniel Kalbacher, MD

Sub-Investigator: Dorit Knappe, MD

Sub-Investigator: Lenard Conradi, MD

Sub-Investigator: Johannes Schirmer, MD

Sub-Investigator: Fabian J Brunner, MD

Sub-Investigator: Christoph Sinning, MD

Sub-Investigator: Peter Moritz-Becher, MD

Sub-Investigator: Peter Clemmensen, MD

Sub-Investigator: Edith Lubos, MD

Sub-Investigator: Julius Nikorowitsch, MD

Sub-Investigator: Lara Waldschmidt, MD

Universitätsklinikum Heidelberg Klinik für Kardiologie, Angiologie, Pneumologie; Recruiting

Heidelberg, Germany, 69120

Contact: Myriam Wittek 49 6221-56-34814 Myriam.Wittek@med.uni-heidelberg.de

Contact: Lisa Freitag 49 6221-56-38203 lisa.freitag@med.uni-heidelberg.de

Sub-Investigator: Matthias Aurich, MD

Sub-Investigator: Gregor Warnecke, MD

Sub-Investigator: Michael Kreußer, MD

Sub-Investigator: Philipp Schlegel, MD

Sub-Investigator: Martin Volz, MD

Sub-Investigator: Nicolas Geis, MD

Principal Investigator: Mathias Konstandin, MD

Sub-Investigator: Dominic Schwab, MD

Sub-Investigator: Rawa Arif, MD

Sub-Investigator: Lorenz Lehmann, MD

Sub-Investigator: Matthias Eden, MD

Sub-Investigator: Fabian aus dem Siepen, MD

Sub-Investigator: Ziya Kaya, MD

Herzzentrum Leipzig Universitätsklinik für Kardiologie; Recruiting

Leipzig, Germany, 04289

Contact: Josephin Kister +49 341 865 251551 Josephin.kister@leipzig-heart.de

Contact: Margit Büttner +49 341 865 1584 Margit.Buettner@leipzig-heart.de

Principal Investigator: Philipp Lurz, MD

Sub-Investigator: Thilo Noack, MD

Sub-Investigator: Philipp Kiefer, MD

Sub-Investigator: Christian Besler, MD

Sub-Investigator: Steffen Desch, MD

Sub-Investigator: Holger Thiele, MD

Sub-Investigator: Maximilian von Roeder, MD

Sub-Investigator: Marcus Sandri, MD

Sub-Investigator: Marion Zimmer, MD

Sub-Investigator: Ricardo Spampinato, MD

Sub-Investigator: Danilo Obradovic, MD

Sub-Investigator: Jörg Ender, MD

Sub-Investigator: Anna Flo Forner, MD

Sub-Investigator: Carmine Bevilacqua, MD

Sub-Investigator: Florian Fahr, MD

Sub-Investigator: Massimiliano Meineri, MD

Sub-Investigator: Johannes Rotta detto Loria, MD

Sub-Investigator: Mateo Marin-Cuartas, MD

Sub-Investigator: Ines Richter, MD

Sub-Investigator: Matthias Lerche, MD

Zentrum für Kardiologie - Kardiologie I Universitätsmedizin der Johannes Gutenberg Universität Mainz; Recruiting

Mainz, Germany, 55131

Contact: Lea Frohnweiler +49 6131-17 2887 Lea.Frohnweiler@unimedizin-mainz.de

Contact: Therese Pauli +49 6131-17 2887 Therese.Pauli@unimedizin-mainz.de

Principal Investigator: Prof. Ralph von Bardeleben, MD

Sub-Investigator: Alexander Tamm, MD

Sub-Investigator: Tobias Ruf, MD

Sub-Investigator: Martin Geyer, MD

Sub-Investigator: Philip Wenzel, MD

Sub-Investigator: Markus Vosseler, MD

Sub-Investigator: Simon Distelmeier, MD

Sub-Investigator: Jaqueline Grace da Rocha e Silva, MD

Sub-Investigator: Martin Oberhoffer, MD

Sub-Investigator: Daniel-Sebastian Dohle, MD

Sub-Investigator: Hendrik Treede, MD

Sub-Investigator: Theresa Gossler, MD

Medizinische Klinik I LMU München Campus Grosshadern; Recruiting

München, Germany, 81377

Contact: Diana Roesler +49 89 4400 76084 diana.roesler@med.uni-muenchen.de

Principal Investigator: Jörg Hausleiter, MD

Sub-Investigator: Michael Näbauer, MD

Sub-Investigator: Daniel Braun, MD

Sub-Investigator: Thomas Johannes Stocker, MD

Sub-Investigator: Sebastian Sadoni, MD

Sub-Investigator: Sven Peterss, MD

Sub-Investigator: Ludwig Weckbach, MD

Helios Klinikum Siegburg; Recruiting

Siegburg, Germany, 53721

Contact: Tino Maudrich +49-2241-182825 Tino.maudrich@helios-gesundheit.de

Principal Investigator: Peter Boekstegers, MD

Sub-Investigator: Harald Beucher, MD

Sub-Investigator: Abdel Karim Al-Ghaddioui, MD

Sub-Investigator: Rolf Hampel-Landsberg, MD

ULM University Zentrum für Innere Medizin Klinik für Innere Medizin II; Recruiting

Ulm, Germany, 89081

Contact: Uta Dichristin +49 731 500 45250 Uta.Dichristin@uniklinik-ulm.de

Principal Investigator: Mirjam Keßler, MD

Sub-Investigator: Sinisa Markovic, MD

Sub-Investigator: Wolfgang Rottbauer, MD

Sub-Investigator: Leonhard Moritz-Schneider, MD

Sub-Investigator: Christine Reichart, MD

Sub-Investigator: Christian Liewald, MD

Sub-Investigator: Matthias Gröger, MD

Sub-Investigator: Maria-Theresa Harris, MD

Sub-Investigator: Jinny Scheffler, MD

Sub-Investigator: Nicoletta Nita, MD

Sub-Investigator: Hagen Gorki, MD

Sub-Investigator: Tillman Dahme, MD

Sub-Investigator: Dominik Buckert, MD

Switzerland

University Hospital Bern; Recruiting

Bern, Switzerland, 3010

Contact: Moreno Trovato +41-31-632-78-50 Moreno.trovato@insel.ch

Contact: Andrea Kristina Suter +41-31-664-16-99 a.suter@insel.ch

Principal Investigator: Fabien Praz, MD

Sub-Investigator: Stephan Windecker, MD

Sub-Investigator: Nicolas Brugger, MD

Sub-Investigator: David Reineke, MD

Sub-Investigator: Lukas Hunziker Munsch, MD

Sub-Investigator: Andrea Ruberti, MD

Sub-Investigator: Daryoush Samim, MD

Sponsors and Collaborators

Edwards Lifesciences

Investigators

• Principal Investigator: Scott Lim, MD; University of Virginia
• Principal Investigator: Robert Smith, MD; The Heart Hospital Baylor Plano
• Principal Investigator: Linda Gillam, MD; Morristown Medical Center
• Principal Investigator: Vinod Thourani, MD; Piedmont Healthcare
• Principal Investigator: Paul Grayburn, MD; The Heart Hospital Baylor Plano
• Principal Investigator: Brian K Whisenant, MD; Intermountain Medical Center
• Principal Investigator: Jörg Hausleiter, MD; LMU München, Campus Gorsshadern
• Principal Investigator: Ralph Stephan von Bardeleben, MD; / Universitätsmedizin Mainz- Zentrum für Kardiologie

More Information

• Responsible Party: Edwards Lifesciences
• ClinicalTrials.gov Identifier: NCT03706833
• Other Study ID Numbers: 2018-07
• First Posted: October 16, 2018
• Last Update Posted: March 2, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

Additional relevant MeSH terms:

Mitral Valve Insufficiency; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases