Cardiovascular Outcomes Assessment of the MitraClip Therapy Percutaneous Therapy for High Surgical Risk Patients (COAPT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Evalve
Sponsor:
Collaborator:
Abbott Vascular
Information provided by (Responsible Party):
Evalve
ClinicalTrials.gov Identifier:
NCT01626079
First received: June 20, 2012
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

The purpose of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation(COAPT) Trial is to confirm the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation (FMR) in Symptomatic Heart Failure Subjects.


Condition Intervention Phase
Mitral Regurgitation
Mitral Valve Regurgitation
Device: MitraClip System
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation

Further study details as provided by Evalve:

Primary Outcome Measures:
  • Primary safety endpoint [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Composite of Single Leaflet Device Attachment (SLDA), device embolizations, endocarditis requiring surgery, Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery, and any device related complications requiring non-elective cardiovascular surgery.

  • Primary effectiveness endpoint [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Recurrent heart failure (HF) hospitalizations


Secondary Outcome Measures:
  • Composite 30 day secondary safety endpoint [ Time Frame: 30 days post-procedure in the Device group ] [ Designated as safety issue: Yes ]
    Composite of death (all-cause), stroke, myocardial infarction (MI), or non-elective cardiovascular surgery for device related complications

  • Mitral Regurgitation severity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in distance walked on the 6 Minute Walk Test (6MWT distance or 6MWD) [ Time Frame: 12 months over baseline ] [ Designated as safety issue: No ]
  • Change in quality of life (QoL) as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: 12 months over baseline ] [ Designated as safety issue: No ]
  • Change in Left Ventricular End Diastolic Volume (LVEDV) [ Time Frame: 12 months over baseline ] [ Designated as safety issue: No ]
  • New York Heart Association (NYHA) Functional Class I/II [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Recurrent hospitalizations - all cause [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • All-cause mortality at 12 months and recurrent HF hospitalization (analyzed when the last subject completes 12 months of follow-up) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Freedom from all-cause mortality at 12 months will be a secondary measure of safety


Other Outcome Measures:
  • Cardiopulmonary exercise testing sub-study endpoint [ Time Frame: baseline and 12 months ] [ Designated as safety issue: No ]
    A sub-study endpoint will utilize peak oxygen consumption oxygen uptake (VO2) as a parameter for cardiopulmonary exercise testing on a total of at least 50 and up to 100 subjects. Mean changes in peak VO2 (ml/kg/min) will be summarized at 12 months from baseline.


Estimated Enrollment: 430
Study Start Date: August 2012
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Percutaneous mitral valve repair using MitraClip System Device: MitraClip System
Percutaneous mitral valve repair using MitraClip System
Other Names:
  • MitraClip device
  • MitraClip
No Intervention: Control Group
Patients with mitral regurgitation managed non-surgically based on standard hospital clinical practice.

Detailed Description:

Prospective, randomized, parallel-controlled, multicenter clinical evaluation of the MitraClip device for the treatment of clinically significant functional mitral regurgitation in symptomatic heart failure subjects who are treated per standard of care and who have been determined by the site's local heart team as not appropriate for mitral valve surgery. Eligible subjects will be randomized in a 1:1 ratio to the MitraClip device (Device group) or to no MitraClip device (Control group).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Symptomatic functional MR (≥3+) due to cardiomyopathy of either ischemic or non-ischemic etiology determined by assessment of a qualifying transthoracic echocardiogram (TTE) obtained within 90 days and transesophageal echocardiogram (TEE) obtained within 180 days prior to subject registration, with MR severity based principally on the TTE study, and must be confirmed by the Echocardiography Core Lab (ECL). The ECL may request a transesophageal echocardiogram (TEE) to confirm MR etiology.

    Note: Functional MR requires the presence of global or regional left ventricular wall motion abnormalities, which are believed to be the primary cause of the MR. If a flail leaflet or other evidence of degenerative MR is present, the subject is not eligible even if global or regional left ventricular systolic dysfunction is present.

    Note: Qualifying TTE must be obtained after the subject has been stabilized on optimal therapy and at least 30 days after:

    1. any change in guideline-directed medical therapy
    2. revascularization and/or implant of Cardiac Resynchronization Therapy device (CRT or CRT-D) or reprogramming of an implanted CRT or CRT-D that results in increased biventricular pacing (from <92% to ≥92%)
  2. In the judgment of the HF specialist investigator at the site, the subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, mitral regurgitation and heart failure (e.g., with cardiac resynchronization therapy, revascularization, and/or optimal medical therapy as appropriate. The Eligibility Committee must also concur that the subject has been adequately treated.
  3. New York Heart Association (NYHA) Functional Class II, III or ambulatory IV.
  4. The Local Site Heart Team (CT surgeon and HF specialist investigators) and the Central Eligibility Committee concur that surgery will not be offered as a treatment option and that medical therapy is the intended therapy for the subject, even if the subject is randomized to the Control group.
  5. The subject has had at least one hospitalization for heart failure in the 12 months prior to subject registration and/or a corrected brain natriuretic peptide (BNP) ≥300 pg/ml or corrected n-Terminal pro- brain natriuretic peptide NT-proBNP ≥1500 pg/ml measured within 90 days prior to subject registration ("corrected" refers to a 4% reduction in the BNP or NT-proBNP cutoff for every increase of 1 kg/m2 in BMI above a reference BMI of 20 kg/m2).

    Note: BNP or NT-proBNP must be obtained after the subject has been stabilized on optimal therapy and at least 30 days after:

    1. any change in guideline-directed medical therapy
    2. revascularization and/or implant of Cardiac Resynchronization Therapy device (CRT or CRT-D) or reprogramming of an implanted CRT or CRT-D that results in increased biventricular pacing (from <92% to ≥92%).
  6. Left Ventricular Ejection Fraction (LVEF) is ≥20% and ≤50% within 90 days prior to subject registration, assessed by the site using any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac magnetic resonance imaging (MRI).
  7. The primary regurgitant jet is non-commissural, and in the opinion of the MitraClip implanting investigator can be successfully be treated by the MitraClip. If a secondary jet exists, it must be considered clinically insignificant.
  8. Creatine Kinase-MB (CK-MB) obtained within prior 14 days < local laboratory Upper Limit of Normal (ULN).
  9. Transseptal catheterization and femoral vein access is determined to be feasible by the MitraClip implanting investigator.
  10. Age 18 years or older.
  11. The subject or the subject's legal representative understands and agrees that should he/she be assigned to the Control group, he/she will be treated with medical therapy and conservative management without surgery and without the MitraClip, either domestically or abroad. If the subject would actively contemplate surgery and/or MitraClip if randomized to Control, he/she should not be registered in this trial.
  12. The subject or the subject's legal representative has been informed of the nature of the trial and agrees to its provisions, including the possibility of randomization to the Control group and returning for all required post-procedure follow-up visits, and has provided written informed consent.

Exclusion Criteria:

  1. Untreated clinically significant coronary artery disease requiring revascularization.
  2. Coronary artery bypass grafting (CABG) within 30 days prior to subject registration.
  3. Percutaneous coronary intervention within 30 days prior to subject registration.
  4. Tricuspid valve disease requiring surgery.
  5. Aortic valve disease requiring surgery.
  6. Cerebrovascular accident within 30 days prior to subject registration.
  7. Severe symptomatic carotid stenosis (> 70% by ultrasound).
  8. Carotid surgery within 30 days prior to subject registration.
  9. American College of Cardiology /American Heart Association (ACC/AHA) Stage D heart failure.
  10. Presence of any of the following:

    • Estimated pulmonary artery systolic pressure (PASP) > 70 mm Hg assessed by site based on echocardiography or right heart catheterization, unless active vasodilator therapy in the cath lab is able to reduce the pulmonary vascular resistance (PVR) to < 3 Wood Units or between 3 and 4.5 Wood Units with v wave less than twice the mean of the pulmonary capillary wedge pressure
    • Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non ischemic etiology
    • Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis)
    • Hemodynamic instability requiring inotropic support or mechanical heart assistance.
  11. Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction.
  12. Implant of any Cardiac Resynchronization Therapy (CRT) or Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D) within the last 30days prior to subject registration.
  13. Mitral valve orifice area < 4.0 cm2 assessed by site based on a transthoracic echocardiogram (TTE) within 90 days prior to subject registration.
  14. Leaflet anatomy which may preclude MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in MR by the MitraClip. This evaluation is based on transesophageal echocardiogram (TEE) evaluation of the mitral valve within 180 days prior to subject registration and includes:

    • Insufficient mobile leaflet available for grasping with the MitraClip device
    • Evidence of calcification in the grasping area
    • Presence of a significant cleft in the grasping area
    • Lack of both primary and secondary chordal support in the grasping area
    • Leaflet mobility length < 1 cm
  15. Hemodynamic instability defined as systolic pressure < 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device.
  16. Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.
  17. Life expectancy < 12 months due to non-cardiac conditions.
  18. Modified Rankin Scale ≥ 4 disability.
  19. Status 1 heart transplant or prior orthotopic heart transplantation.
  20. Prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure.
  21. Echocardiographic evidence of intracardiac mass, thrombus or vegetation.
  22. Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease (i.e., noncompliant, perforated).
  23. Active infections requiring current antibiotic therapy.
  24. Subjects in whom transesophageal echocardiography (TEE) is contraindicated or high risk.
  25. Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically.
  26. Pregnant or planning pregnancy within next 12 months.

    Note: Female patients of childbearing age should be instructed to use safe contraception (e.g. intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release. It is accepted in certain cases to include subjects having a sterilized regular partner or subjects using a double barrier contraceptive method. However, this should be explicitly justified in special circumstances arising from the study design, product characteristics and/or study population.

  27. Currently participating in an investigational drug or another device study that has not reached its primary endpoint. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
  28. Subject belongs to a vulnerable population per investigator's judgment or subject has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01626079

Contacts
Contact: Vinod Charnani 650 833-4315 vinod.charnani@abbott.com
Contact: Robin Eckert 650 833-1712 robin.eckert@av.abbott.com

  Hide Study Locations
Locations
United States, California
Scripps Green Hospital Recruiting
La Jolla, California, United States, 92037
Contact: Matthew Price, MD    858-554-9905    price.matthew@scrippshealth.org   
Principal Investigator: Matthew Price, MD         
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Saibal Kar, MD    310-423-3978    karsk@cshs.org   
Principal Investigator: Saibal Kar, MD         
University California Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Jason Rogers, MD    916-734-3764    jason.rogers@ucdmc.ucdavis.edu   
Principal Investigator: Jason Rogers, MD         
Kaiser Permanente Recruiting
San Francisco, California, United States, 94118
Contact: Jacob Mishell, MD    415-833-6016    jacob.mishell@kp.org   
Principal Investigator: Jacob Mishell, MD         
United States, Colorado
Univ of Colorado Hospital Recruiting
Denver, Colorado, United States, 80045
Contact: Andreas Brieke, MD    303-724-2102    Andreas.brieke@ucdenver.edu   
Principal Investigator: Andreas Brieke, MD         
United States, District of Columbia
Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Kenneth Kent, MD    202-877-5975    kenneth.m.kent@medstar.net   
Principal Investigator: Kenneth Kent, MD         
United States, Florida
Mount Sinai Hospital Recruiting
Miami, Florida, United States, 33140
Contact: Nirat Beohar, MD    305-674-2754    Nirat.Beohar@msmc.com   
Principal Investigator: Nirat Beohar, MD         
Florida Hospital Recruiting
Orlando, Florida, United States, 32822
Contact: Andy Taussig, MD    321-499-4178    astaussig@aol.com   
Principal Investigator: Andy Taussig, MD         
Sarasota Memorial Hospital Recruiting
Sarasota, Florida, United States, 34239
Contact: Ricardo Yaryura, MD    941-917-2225    Sdobson@intercoastalmedical.com   
Principal Investigator: Ricardo Yaryura, MD         
Tallahassee Memorial Recruiting
Tallahassee, Florida, United States, 32308
Contact: Wayne Batchelor, MD    850-216-0120    wabat@southern-med.com   
Principal Investigator: Wayne Batchelor, MD         
United States, Georgia
Piedmont Hospital Recruiting
Atlanta, Georgia, United States, 30309
Contact: Vivek Rajagopal, MD    404-605-2800    vivek.rajagopal@piedmont.org   
Principal Investigator: Vivek Rajagopal, MD         
St. Joseph's Hospital - Atlanta Recruiting
Atlanta, Georgia, United States, 30342
Contact: Louis Heller, MD    770-962-0399    lhellermd@aol.com   
Principal Investigator: Louis Heller, MD         
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Vasilis Babaliaros, MD    404-712-0131    vbabali@emory.edu   
Principal Investigator: Vasilis Babaliaros, MD         
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Mark J Ricciardi, MD    312-695-4965    mricciar@nmff.org   
Principal Investigator: Patrick McCarthy, MD         
Evanston Northwestern Healthcare Recruiting
Evanston, Illinois, United States, 60201
Contact: Ted Feldman, MD    847-570-2250    tfeldman@northshore.org   
Principal Investigator: Ted E Feldman, MD         
United States, Indiana
The Care Group Heart Center 10590 N. Meridian, Ste. 300 Recruiting
Indianapolis, Indiana, United States, 46290
Contact: James Hermiller, MD    317-583-6044    jhermill@thecaregroup.com   
Principal Investigator: Jim Hermiller, MD         
United States, Iowa
Iowa Heart Center Recruiting
Des Moines, Iowa, United States, 50309
Contact: Magdi Ghali, MD    515-633-3600    mghali@iowaheart.com   
Principal Investigator: Magdi Ghali, MD         
United States, Kentucky
St. Joseph's Hospital Recruiting
Lexington, Kentucky, United States, 40504
Contact: Robert Salley, MD    859-977-0898    robertsalley@catholichealth.net   
Principal Investigator: Robert Salley, MD         
United States, Maine
Maine Medical Center Recruiting
Portland, Maine, United States, 04102
Contact: Mirle Kellet, Jr, MD    207-662-2414    kellem@mmc.org   
Principal Investigator: Mirle Kellet, Jr, MD         
United States, Maryland
University of Maryland Baltimore Recruiting
Baltimore, Maryland, United States, 21201
Contact: Mark Vesley, MD    410-328-5842    mvesely@medicine.umaryland.edu   
Principal Investigator: Mark Vesley, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Igor Palacios, MD    617-726-8424    ipalacios@partners.org   
Principal Investigator: Igor Palacios, MD         
Brigham Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Andy Eisenhauer, MD    857-307-1991    AEISENHAUER@PARTNERS.ORG   
Principal Investigator: Andy Eisenhauer, MD         
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Adam Greenbaum, M.D    313-916-3875    AGREENB1@hfhs.org   
Principal Investigator: Adam Greenbaum, M.D         
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Contact: George Hanzel, MD    248-898-5242    ghanzel@beaumont.edu   
Principal Investigator: George Hanzel, MD         
United States, Minnesota
Minneapolis Heart Institute Foundation Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Wesley Pedersen, MD    612-863-3925    wesley.pedersen@allina.com   
Principal Investigator: Wesley Pedersen, MD         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55902
Contact: Charanjit Rihal, MD    507-255-2440    rihal@mayo.edu   
Principal Investigator: Charanjit Rihal, MD         
United States, Missouri
Washington University Medical Center Recruiting
St. Louis, Missouri, United States, 63110
Contact: John Lasala, MD, PhD    314-362-3729    jlasala@dom.wustl.edu   
Principal Investigator: John Lasala, MD, PhD         
United States, Montana
St. Patrick Hospital Recruiting
Missoula, Montana, United States, 59802
Contact: Mark Sanz, MD    406-329-5615    msanz@ihimontana.org   
Principal Investigator: Mark Sanz, MD         
United States, New Jersey
Morristown Medical Center Recruiting
Morristown, New Jersey, United States, 07960
Contact: Robert Kipperman, MD    973-467-0005    rkipperman@okheart.com   
Principal Investigator: Robert Kipperman, MD         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: William Gray, MD    212-305-7060    wg2131@mail.cumc.columbia.edu   
Principal Investigator: William Gray, MD         
NYU Medical Center Recruiting
New York, New York, United States, 10016
Contact: James Slater, MD    212-263-5656    james.slater@nyumc.org   
Principal Investigator: James Slater, MD         
Mount Sinai Hospital - NY Recruiting
New York, New York, United States, 10029
Contact: Samin Sharma, MD    212-427-1540    samin.sharma@mountsinai.org   
Principal Investigator: Samin Sharma, MD         
United States, North Carolina
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Michael J Rinaldi, MD    704-355-4794    Michael.Rinaldi@carolinashealthcare.org   
Principal Investigator: Michael J Rinaldi, MD         
Duke University Hospital Recruiting
Durham, North Carolina, United States, 27710
Contact: Andrew Wang, MD    919-681-6197    a.wang@duke.edu   
Principal Investigator: Andrew Wang, MD         
United States, Ohio
Lindner Center at Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Ian Sarembock, MD    513-585-1777    sarembock@ohioheart.org   
Principal Investigator: Ian Sarembock, MD         
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Samir Kapadia, MD    216-444-6697    kapadis@ccf.org   
Principal Investigator: Samir Kapadia, MD         
Ohio Health Research Institute/Riverside Methodist Hospital Recruiting
Columbus, Ohio, United States, 43214
Contact: Steven Yakubov, MD    614-566-1250    steven.yakubov@gmail.com   
Principal Investigator: Steven Yakubov, MD         
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Juan Crestanello, MD    614-293-8866    juan.crestanello@osumc.edu   
Principal Investigator: Juan Crestanello, MD         
United States, Oklahoma
Oklahoma Heart Hospital Recruiting
Oklahoma City, Oklahoma, United States, 73120
Contact: Mohammad Ghani, MD    405-608-3800    mghani@ohkeart.com   
Principal Investigator: Mohammad Ghani, MD         
United States, Oregon
Providence St. Vincent Medical Center Recruiting
Portland, Oregon, United States, 97225
Contact: Ethan Korngold, MD    503-216-0900    Ethan.Korngold@providence.org   
Principal Investigator: Ethan Korngold, MD         
United States, Pennsylvania
Hospital of University Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Howard C Herrmann, MD    215-662-2180    howard.herrmann@uphs.upenn.edu   
Principal Investigator: Howard Herrmann, MD         
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Howard Cohen, MD    215-707-2230    howard.cohen@tuhs.temple.edu   
Principal Investigator: Howard Cohen, MD         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Anson Jay C Smith, M.D.    412-647-8117    smithaj@upmc.edu   
Principal Investigator: Anson Jay C Smith, M.D.         
Pinnacle Health at Harrisburg Hospital Recruiting
Wormleysburg, Pennsylvania, United States, 17043
Contact: Brijeshwar Maini, MD    717-731-0101    bmaini@pinnaclehealth.org   
Principal Investigator: Brijeshwar Maini, MD         
United States, Tennessee
St. Thomas Hospital Recruiting
Nashville, Tennessee, United States, 37205
Contact: Evelio Rodriguez, MD    615-222-5500    evelio.rodriguez@stthomas.org   
Principal Investigator: Evelio Rodriguez, MD         
United States, Texas
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75246
Contact: Micheal Mack Micheal Mack, MD    214-820-7358    michael.mack@baylorhealth.edu   
Principal Investigator: Michael Mack, MD         
Memorial Hermann Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Richard Smalling, MD, PhD    713-500-6559    richard.w.smalling@uth.tmc.edu   
Principal Investigator: Richard Smalling, MD, PhD         
The Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Neal Kleiman, MD    713-441-1100    nkleiman@tmhs.org   
Principal Investigator: Neal Kleiman, MD         
United States, Utah
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84157
Contact: Brian Whisenant, MD    801-507-4700    brian.whisenant@imail.org   
Principal Investigator: Brian Whisenant, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Scott Lim, MD    434-982-1058    sl9pc@virginia.edu   
Principal Investigator: Scott Lim, MD         
United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98122
Contact: Mark Reisman, MD    206-861-8550    mark.reisman@swedish.org   
Principal Investigator: Mark Reisman, MD         
United States, Wisconsin
Aurora St. Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Tanvir Bajwa, MD    414-219-7666    doris.payne@aurora.org   
Principal Investigator: Tanvir Bajwa, MD         
Sponsors and Collaborators
Evalve
Abbott Vascular
Investigators
Principal Investigator: Michael Mack, MD Baylor Health Care System
Principal Investigator: Gregg Stone, MD Columbia University Medical Center / New York-Presbyterian Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Evalve
ClinicalTrials.gov Identifier: NCT01626079     History of Changes
Other Study ID Numbers: 11-512
Study First Received: June 20, 2012
Last Updated: March 5, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 30, 2014