Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial (CLASP II TR)

• ClinicalTrials.gov Identifier: NCT04097145
• Recruitment Status: Recruiting
• First Posted: September 20, 2019
• Last Update Posted: June 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 Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the local Heart Team

Condition or disease	Intervention/treatment	Phase
Tricuspid Regurgitation; Tricuspid Valve Insufficiency; Tricuspid Valve Disease	Device: Edwards PASCAL System; Drug: Optimal Medical Therapy	Not Applicable

Detailed Description:

A Prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid regurgitation. Patients will be seen for follow-up visits at discharge, 30 days, 3 months, 6 months, and annually through 5 years.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 870 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Tricuspid Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System and Optimal Medical Therapy (OMT) Compared to OMT Alone in Patients With Tricuspid Regurgitation
• Actual Study Start Date: December 11, 2019
• Estimated Primary Completion Date: December 31, 2024
• Estimated Study Completion Date: March 31, 2029

Arms and Interventions

Arm	Intervention/treatment
Experimental: Edwards PASCAL System & OMT; Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation	Device: Edwards PASCAL System; Transcatheter tricuspid valve repair with the Edwards PASCAL System in patients on optimal medical therapy; Other Name: Transcatheter tricuspid valve repair (TTVr)
Active Comparator: Optimal Medical Therapy (OMT); Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation	Drug: Optimal Medical Therapy; Optimal Medical Therapy alone in patients with tricuspid regurgitation
Experimental: Single-Arm Registry; Transcatheter tricuspid valve repair with the Edwards PASCAL System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation who are not eligible for randomization	Device: Edwards PASCAL System; Transcatheter tricuspid valve repair with the Edwards PASCAL System in conjunction with OMT

Outcome Measures

Primary Outcome Measures :

1. Composite endpoint including all-cause mortality, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalizations, and Quality of Life improvement (measured by KCCQ score) [ Time Frame: 24 months ]
   Comparison of number of participants with composite endpoint events between experimental and active comparator arms

Secondary Outcome Measures :

1. 1 Grade Reduction in TR Severity [ Time Frame: 12 months ]
   Total number of participants with at least 1 grade reduction in TR severity
2. Quality of Life (QOL) as Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: 12 months ]
   Change in KCCQ score from baseline
3. All Cause Mortality [ Time Frame: 12 months, 24 months ]
   Total number of deaths from any cause
4. Death and Heart Failure Hospitalizations [ Time Frame: 12 months ]
   Total number of deaths and hospital admissions due to heart failure
5. All-cause Hospitalization [ Time Frame: 12 months ]
   Total number of hospitalizations due to any cause
6. Right ventricular end-diastolic diameter (RVEDD mid) [ Time Frame: 12 months ]
   Change in right ventricular end-diastolic diameter (RVEDD mid)
7. Major Adverse Events (MAEs) [ Time Frame: 30 days ]
   Overall rate of Major Adverse Events (MAEs)
8. Reduction in TR grade [ Time Frame: Intraprocedural post-implantation ]
   Reduction in TR severity as assessed by TEE pre- and post-implantation
9. All-Cause Mortality [ Time Frame: 12 months, annually through 5 years ]
   Total number of deaths from any cause
10. Heart failure hospitalizations [ Time Frame: 12 months, annually through 5 years ]
    Total number of hospital admissions due to heart failure
11. Non-elective tricuspid valve re-intervenitions (percutaneous or surgical) [ Time Frame: 12 months, annually through 5 years ]
    Total number of non-elective tricuspid valve re-interventions
12. Durable RVAD implantation or heart transplant [ Time Frame: 12 months, annually through 5 years ]
    Total number of patients requiring RVAD impantantion or heart transplant
13. Need for paracentesis [ Time Frame: 12 months, annually through 5 years ]
    Total nunber of patients who required paracentesis

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
• Despite medical therapy, per the local Heart Team, patient has signs of TR, symptoms from TR, or prior heart failure hospitalization from TR.
• Severe or greater tricuspid regurgitation
• New York Heart Association (NYHA) Class II-IVa or heart failure hospitalization in the prior 12 months
• Patient is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the cardiac surgeon with concurrence by the local Heart Team
• Patient is able and willing to give informed consent, follow protocol procedures, and comply with follow-up visit requirements

Exclusion Criteria:

• Tricuspid valve anatomy not evaluable by TTE or TEE
• Tricuspid valve anatomy precludes proper device deployment and function
• Patient with refractory heart failure requiring, advanced intervention (i.e. patient has or will need left ventricular assist device, or transplantation) (ACC/AHA Stage D heart failure)

• Presence of trans-tricuspid pacemaker or defibrillator leads which meet one of the following:

  1. Would prevent proper TR reduction due to interaction of the lead with the leaflets
  2. Were implanted in the RV within the last 90 days prior to the point of enrollment
• Primary non-degenerative tricuspid disease
• Previous tricuspid valve repair or replacement that would interfere with placement of PASCAL
• Clinically significant, untreated coronary artery disease requiring revascularization, unstable angina, evidence of acute coronary syndrome, recent myocardial infarction
• Significant intra-cardiac mass, thrombus, or vegetation per echo core lab assessment
• Deep vein thrombosis (DVT) or pulmonary embolism (PE) in the last 90 days
• Recent Stroke
• Active gastrointestinal (GI) bleeding
• Presence of infiltrative cardiomyopathy or valvulopathy (including carcinoid, amyloidosis, sarcoidosis, hemochromatosis) or significant congenital heart disease, including but not limited to atrial septal defect, RV dysplasia, and arrhythmogenic RV
• Need for emergent or urgent surgery for any reason, any planned cardiac surgery within the next 12 months (365 days), or any planned percutaneous cardiac procedure within the next 90 days

• Any of the following cardiovascular procedures:

  1. Percutaneous coronary, intracardiac, or endovascular intervention within the last 30 days prior to the point of enrollment
  2. Carotid surgery within 30 days prior to the point of enrollment
  3. Direct current cardioversion within the last 30 days prior to the point of enrollment
  4. Leadless RV pacemaker implant within the last 30 days prior to the point of enrollment
  5. Cardiac surgery within 90 days prior to the point of enrollment
• Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation
• Known history of untreated severe symptomatic carotid stenosis or asymptomatic carotid stenosis
• Active endocarditis within the last 90 days or infection requiring antibiotic therapy within the last 14 days
• Patient is oxygen-dependent or requires continuous home oxygen
• Pregnant, breastfeeding, or planning pregnancy within the next 12 months (365 days)
• 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
• Patient has other medical, social, or psychological conditions that preclude appropriate consent and follow-up, or the patient is under guardianship
• Any patient considered to be vulnerable

Contacts and Locations

Contacts

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

Locations

United States, Arizona

Banner University Medical Center Phoenix; Recruiting

Phoenix, Arizona, United States, 85006

Principal Investigator: Marvin Eng, MD

Tucson Medical Center Healthcare; Recruiting

Tucson, Arizona, United States, 85712

Principal Investigator: Thomas Waggoner, DO

United States, California

SCPMG - Kaiser San Diego; Recruiting

La Jolla, California, United States, 92037

Principal Investigator: Bahram Khadivi, MD

Cedars Sinai Medical Center; Recruiting

Los Angeles, California, United States, 90048

Principal Investigator: Raj Makkar, MD

UCLA Medical Center; Recruiting

Los Angeles, California, United States, 90095

Principal Investigator: Marcella Press, MD

Kaiser Permanente San Francisco; Recruiting

San Francisco, California, United States, 94118

Principal Investigator: Andrew Rassi, MD

Principal Investigator: Jacob Mishell, MD

University of California, San Francisco; Recruiting

San Francisco, California, United States, 94143

Principal Investigator: Sammy Elmariah, MD

Stanford University; Recruiting

Stanford, California, United States, 94305

Principal Investigator: Rahul Sharma, MD

United States, Colorado

Medical Center of the Rockies; Recruiting

Loveland, Colorado, United States, 80538

Principal Investigator: Mohamad Lazkani, MD

United States, Florida

The Cardiac and Vascular Institute Research Foundation; Recruiting

Gainesville, Florida, United States, 32605

Principal Investigator: Charles Klodell, MD

Principal Investigator: Ilie Barb, MD

Mount Sinai Medical Center; Recruiting

Miami Beach, Florida, United States, 33140

Principal Investigator: Nirat Beohar, MD

Principal Investigator: Steve Xydas, MD

NCH Healthcare System; Recruiting

Naples, Florida, United States, 34102

Principal Investigator: Robert Cubeddu, MD

Sarasota Memorial Health Care System; Recruiting

Sarasota, Florida, United States, 34239

Principal Investigator: Ricardo A. Yaryura, MD

United States, Georgia

Emory University Hospital Midtown / Emory University - St. Joseph's Hospital; Recruiting

Atlanta, Georgia, United States, 30308

Principal Investigator: Adam Greenbaum, MD

United States, Illinois

Northwestern University; Recruiting

Chicago, Illinois, United States, 60611

Principal Investigator: Charles Davidson, MD

United States, Indiana

Ascension St. Vincent Heart Center Cardiovascular Research Institute; Recruiting

Indianapolis, Indiana, United States, 46290

Principal Investigator: James Hermiller, MD

United States, Iowa

University of Iowa Hospitals & Clinics; Recruiting

Iowa City, Iowa, United States, 52242

Principal Investigator: Phillip A. Horwitz, MD

United States, Louisiana

Ochsner Medical Center; Recruiting

New Orleans, Louisiana, United States, 70121

Principal Investigator: J. Stephen Jenkins, MD

United States, Maryland

Johns Hopkins; Recruiting

Baltimore, Maryland, United States, 21287

Principal Investigator: Rani Hasan, MD

United States, Massachusetts

Massachusetts General Hospital; Recruiting

Boston, Massachusetts, United States, 02114

Principal Investigator: Nilay Patel, MD

Principal Investigator: Ignacio Inglessis, MD

United States, Michigan

University of Michigan; Recruiting

Ann Arbor, Michigan, United States, 48109

Principal Investigator: Stanley Chetcuti, MD

Henry Ford Hospital; Recruiting

Detroit, Michigan, United States, 48202

Principal Investigator: Brian O' Neill, MD

William Beaumont Hospital - Royal Oak; Recruiting

Royal Oak, Michigan, United States, 48073

Principal Investigator: Ivan Hanson, MD

St. Mary's of Ascension Research; Recruiting

Saginaw, Michigan, United States, 48601

Principal Investigator: Safwan Kassas, MD

United States, Minnesota

Fairview Health Services; Recruiting

Maplewood, Minnesota, United States, 55109

Principal Investigator: Marat Yanavitski, MD

Mayo Clinic; Recruiting

Rochester, Minnesota, United States, 55905

Principal Investigator: Mackram Eleid, MD

United States, Missouri

Saint Luke's Hospital of Kansas City; Recruiting

Kansas City, Missouri, United States, 64111

Principal Investigator: Adnan Chhatriwalla, MD

Washington University School of Medicine; Recruiting

Saint Louis, Missouri, United States, 63110

Principal Investigator: Alan Zajarias, MD

Principal Investigator: Puja Kachroo, MD

United States, Montana

Providence St. Patrick Hospital; Recruiting

Missoula, Montana, United States, 59802

Principal Investigator: James Maddux, MD

Principal Investigator: Daniel Spoon, MD

United States, New Hampshire

Dartmouth-Hitchcock Medical Center; Recruiting

Lebanon, New Hampshire, United States, 03756

Principal Investigator: Michael Young, MD

United States, New Jersey

Cooper Health Systems; Recruiting

Camden, New Jersey, United States, 09103

Principal Investigator: Sajjad Sabir, MD

Morristown Medical Center; Recruiting

Morristown, New Jersey, United States, 07962

Principal Investigator: Robert Kipperman, MD

Rutgers Robert Wood Johnson Medical School; Recruiting

New Brunswick, New Jersey, United States, 08901

Principal Investigator: Mark Russo, MD

United States, New York

Montefiore Medical Center / Arts Pavilion / Hutchinson Metro Center Clinic / Weiler Hospital / Moses Hospital; Recruiting

Bronx, New York, United States, 10467

Principal Investigator: Mohamed A. Latib, MD

State University of New York at Buffalo; Recruiting

Buffalo, New York, United States, 14203

Principal Investigator: Vijay Iyer, MD, PhD

Columbia University Irving Medical Center/NYPH; Recruiting

New York, New York, United States, 10032

Principal Investigator: Susheel Kodali, MD

Weill Cornell Medicine; Recruiting

New York, New York, United States, 10065

Principal Investigator: Mark Reisman, MD

Lenox Hill Hospital, Northwell Health /Northshore University Hospital Manhasset; Recruiting

New York, New York, United States, 10075

Principal Investigator: Chad Kliger, MD

Principal Investigator: Bruce Rutkin, MD

Rochester General Hospital; Recruiting

Rochester, New York, United States, 14621

Principal Investigator: Jeremiah Depta, MD

St. Francis Hospital; Recruiting

Roslyn, New York, United States, 11576

Principal Investigator: George A. Petrossian, MD

Principal Investigator: Newell B. Robinson, MD

United States, North Carolina

University of North Carolina; Recruiting

Chapel Hill, North Carolina, United States, 27517

Principal Investigator: John Vavalle, MD

United States, North Dakota

Sanford Medical Center Fargo; Recruiting

Fargo, North Dakota, United States, 58104

Principal Investigator: Thomas Haldis, DO

United States, Ohio

The Christ Hospital; Recruiting

Cincinnati, Ohio, United States, 45219

Principal Investigator: Santiago Garcia, MD

TriHealth-Bethesda North Hospital; Recruiting

Cincinnati, Ohio, United States, 45242

Principal Investigator: Mohammed Al-Amoodi, MD

The Ohio State University; Recruiting

Columbus, Ohio, United States, 43210

Principal Investigator: Konstantinos Boudoulas, MD

Principal Investigator: Scott Lilly, MD

United States, Oklahoma

Integris Baptist Medical Center; Recruiting

Oklahoma City, Oklahoma, United States, 73112

Principal Investigator: Jeffrey Sparling, MD

Oklahoma Cardiovascular Research Group; Recruiting

Oklahoma City, Oklahoma, United States, 73120

Principal Investigator: Mohammad Ghani, MD

Oklahoma Heart Institute at Hillcrest Medical Center; Recruiting

Tulsa, Oklahoma, United States, 74104

Principal Investigator: Kamran Muhammad, MD

United States, Oregon

Oregon Health & Science University; Recruiting

Portland, Oregon, United States, 97239

Principal Investigator: Firas Zahr, MD

Principal Investigator: Scott Chadderdon, MD

United States, Pennsylvania

Penn State Hershey; Recruiting

Hershey, Pennsylvania, United States, 17033

Principal Investigator: Mark Kozak, MD

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

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator: Gene Chang, MD

Principal Investigator: Wilson Szeto, MD

Pinnacle Health Cardiovascular Institute/UPMC Pinnacle; Recruiting

Wormleysburg, Pennsylvania, United States, 17043

Principal Investigator: Mubashir Mumtaz, MD

Principal Investigator: Hemal Gada, MD

Lankenau Heart Institute; Recruiting

Wynnewood, Pennsylvania, United States, 19096

Principal Investigator: William Gray, MD

United States, South Carolina

Medical University of South Carolina; Recruiting

Charleston, South Carolina, United States, 29245

Principal Investigator: Nicholas Amoroso, MD

United States, Tennessee

Erlanger Health System; Recruiting

Chattanooga, Tennessee, United States, 37403

Principal Investigator: Megan Coylewright, MD

Vanderbilt University Medical Center; Recruiting

Nashville, Tennessee, United States, 37212

Principal Investigator: Colin Barker, MD

Principal Investigator: Brian R. Lindman, MD

United States, Texas

HCA Houston Healthcare Medical Center; Recruiting

Houston, Texas, United States, 77004

Principal Investigator: Pranav Loyalka, MD

Baylor College of Medicine St. Luke's Medical Center; Recruiting

Houston, Texas, United States, 77030

Principal Investigator: Guilherme Silva, MD

The University of Texas Health Science Center at Houston; Recruiting

Houston, Texas, United States, 77030

Principal Investigator: Abhijeet Dhoble, MD

Principal Investigator: Richard Smalling, MD

UTHealth/Memorial Hermann Hospital; Recruiting

Houston, Texas, United States, 77030

Principal Investigator: Biswajit Kar, MD

Baylor Scott & White - The Heart Hospital - Plano; Recruiting

Plano, Texas, United States, 75093

Principal Investigator: Molly Szerlip, MD

United States, Virginia

University of Virginia Health System; Recruiting

Charlottesville, Virginia, United States, 22908

Principal Investigator: Scott Lim, MD

Virginia Commonwealth University; Recruiting

Richmond, Virginia, United States, 23298

Principal Investigator: Zachary Gertz, MD

Carilion Medical Center; Recruiting

Roanoke, Virginia, United States, 24014

Principal Investigator: Jason Foerst, MD

United States, Washington

Swedish Medical Center; Recruiting

Seattle, Washington, United States, 98122

Principal Investigator: Sameer Gafoor, MD

United States, Wisconsin

Medical College of Wisconsin; Recruiting

Milwaukee, Wisconsin, United States, 53226

Principal Investigator: Peter Mason, MD, MPH

Canada, British Columbia

St. Paul's Hospital; Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Principal Investigator: Robert Boone, MD

Canada, Ontario

St. Michael's Hospital; Recruiting

Toronto, Ontario, Canada, M5B 1W8

Principal Investigator: Neil Fam, MD

Canada

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval; Recruiting

Québec, Canada, G1V 4G5

Principal Investigator: Josep Rodés-Cabau, MD

Sponsors and Collaborators

Edwards Lifesciences

Investigators

• Principal Investigator: Martin B. Leon, MD; Columbia University
• Principal Investigator: Michael J. Mack, MD; Baylor Scott and White Health
• Principal Investigator: Charles Davidson, MD; Northwestern University
• Study Chair: Allen Anderson, MD; UT Health San Antonio
• Study Chair: Gorav Ailawadi, MD; University of Michigan

More Information

• Responsible Party: Edwards Lifesciences
• ClinicalTrials.gov Identifier: NCT04097145
• Other Study ID Numbers: 2019-07
• First Posted: September 20, 2019
• Last Update Posted: June 2, 2023
• Last Verified: May 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:

Tricuspid Valve Insufficiency; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases