- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03433274
Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT)
Prospective, controlled, multicenter clinical investigation with four trial cohorts: Randomized, Non-repairable, Severe Mitral Annular Calcification (MAC) and Severe Mitral Annular Calcification Continued Access Protocol (MAC CAP). Subjects in the Randomized cohort will be randomized in a 1:1 ratio to the trial device or to the MitraClip system. Subjects in the Non-repairable, Severe MAC, and Severe MAC CAP cohorts will receive the trial device.
The objective of the Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) is to evaluate the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System for the treatment of patients with symptomatic, moderate-to-severe or severe mitral regurgitation or for patients with symptomatic mitral valve disease due to severe mitral annular calcification.
This randomized controlled trial will provide the opportunity to evaluate the safety and clinical benefits of the Tendyne Transcatheter Mitral Valve System compared to the MitraClip System in patients with symptomatic, moderate-to-severe or severe mitral regurgitation, within approved MitraClip indications. In addition, the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System will be evaluated in patients with severe mitral annular calcification who are at prohibitive risk for mitral valve surgery. Patients who are not suitable for mitral valve surgery for reasons other than severe mitral annular calcification and are also not suitable for transcatheter repair with MitraClip, will be enrolled in the Non-repairable cohort.
Subjects will be seen at screening, pre- and post-procedure, discharge, 30 days, 3 months, 6 months, and annually through 5 years.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kayla Dellefratte
- Phone Number: +1 (669)214-9748
- Email: SUMMIT.Trial@abbott.com
Study Contact Backup
- Name: Leslie Ornelas
- Phone Number: +1 (602)692-5047
- Email: leslie.ornelas@abbott.com
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1Y 4W7
- Active, not recruiting
- Ottawa Heart Institute
-
Toronto, Ontario, Canada, M5B 1W8
- Active, not recruiting
- St. Michael's Hospital
-
Toronto, Ontario, Canada
- Active, not recruiting
- Sunnybrook Health Sciences Centre
-
-
Quebec
-
Montreal, Quebec, Canada, H4A 3J1
- Active, not recruiting
- The Royal Victoria Hospital
-
Montréal, Quebec, Canada
- Active, not recruiting
- Montreal Heart Institute
-
-
-
-
Alabama
-
Birmingham, Alabama, United States, 35211
- Terminated
- Princeton Baptist Medical Center
-
Birmingham, Alabama, United States, 35233
- Recruiting
- UAB University Hospital
-
Contact:
- Kathy Phillips
- Email: kcphillips@uabmc.edu
-
Principal Investigator:
- Mustafa Ahmed, M.D.
-
-
Arizona
-
Phoenix, Arizona, United States, 85006
- Recruiting
- Banner-University Medical Center
-
Principal Investigator:
- Philip Gideon, M.D.
-
Contact:
- Carina Schmick
- Email: Carina.Schmick2@bannerhealth.com
-
Scottsdale, Arizona, United States, 85260
- Recruiting
- HonorHealth Scottsdale Shea Medical Center
-
Contact:
- Alexandra Gaughan
- Email: agaughan@honorhealth.com
-
Principal Investigator:
- David Rizik, M.D.
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- Recruiting
- Baptist Health Medical Center
-
Contact:
- Richard Bailey
- Email: richard.bailey@baptist-health.org
-
Principal Investigator:
- Bassam Shukrallah, MD
-
-
California
-
Fresno, California, United States, 93720
- Active, not recruiting
- Fresno Heart Hospital
-
Los Angeles, California, United States, 90048
- Recruiting
- Cedars-Sinai Medical Center
-
Contact:
- Jason Yashar
- Email: Jason.Yashar@cshs.org
-
Principal Investigator:
- Raj Makkar, M.D.
-
Los Angeles, California, United States, 90033
- Terminated
- University of Southern California University Hospital
-
Sacramento, California, United States, 95817
- Recruiting
- University of California - Davis Medical Center
-
Principal Investigator:
- Jason Rogers, M.D.
-
Contact:
- Kimberley Book
- Email: kabook@ucdavis.edu
-
Sacramento, California, United States, 95816
- Terminated
- Sutter Medical Center, Sacramento
-
San Diego, California, United States, 92123
- Recruiting
- San Diego Cardiac Center
-
Principal Investigator:
- Raghava Gollapudi, M.D.
-
Contact:
- Courtney Van Tol
- Email: cvantol@sdcardiac.com
-
San Francisco, California, United States, 94143
- Active, not recruiting
- University of California at San Francisco
-
Stanford, California, United States, 94304
- Recruiting
- Stanford Health Care
-
Principal Investigator:
- Rahul Sharma, M.D.
-
Contact:
- Sana Kidwai
- Email: kidwai@stanford.edu
-
Thousand Oaks, California, United States, 91360
- Recruiting
- Los Robles Hospital and Medical Center
-
Contact:
- Mane Arabyan
- Email: Mane.Arabyan@HCAHealthcare.com
-
Principal Investigator:
- Gregory Fontana, M.D.
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Terminated
- University of Colorado Hospital
-
-
Florida
-
Bradenton, Florida, United States, 34208
- Active, not recruiting
- Manatee Memorial Hospital
-
Clearwater, Florida, United States, 33756
- Recruiting
- Morton Plant Hospital
-
Contact:
- Sue Fisher
- Email: Susan.Fisher1@baycare.org
-
Principal Investigator:
- Joshua Rovin, M.D.
-
Delray Beach, Florida, United States, 33484
- Terminated
- Delray Medical Center
-
Gainesville, Florida, United States, 32610
- Recruiting
- Shands at the University of Florida
-
Principal Investigator:
- Thomas Beaver, M.D.
-
Contact:
- Jessica Cobb
- Email: jessica.cobb@surgery.ufl.edu
-
Gainesville, Florida, United States, 32605
- Active, not recruiting
- North Florida Regional Medical Center
-
Miami, Florida, United States, 33176
- Active, not recruiting
- Baptist Hospital of Miami
-
Tallahassee, Florida, United States, 32308
- Recruiting
- Tallahassee Research Institute
-
Contact:
- Dana Porter
- Email: Dana.porter@tmh.org
-
Principal Investigator:
- Thomas Noel, M.D.
-
Weston, Florida, United States, 33331
- Recruiting
- Cleveland Clinic Florida
-
Principal Investigator:
- Samir Kapadia, M.D.
-
Contact:
- Maria Mejia-Gomez
- Email: mejiagm@ccf.org
-
Sub-Investigator:
- Mauricio Cohen, M.D.
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Recruiting
- Emory University Hospital
-
Contact:
- Maria Kaner
- Email: maria.kaner@emory.edu
-
Principal Investigator:
- Vasilis Babaliaros, M.D.
-
Atlanta, Georgia, United States, 30309
- Recruiting
- Piedmont Heart Institute
-
Contact:
- Brittney Truss
- Email: Brittney.Truss@piedmont.org
-
Principal Investigator:
- Vinod Thourani, M.D.
-
Principal Investigator:
- Pradeep Yadav, M.D.
-
Marietta, Georgia, United States, 30060
- Recruiting
- Wellstar Kennestone Hospital
-
Principal Investigator:
- Amar Patel, MD
-
Contact:
- Jennifer Cuvo
- Email: Jennifer.Cuvo@wellstar.org
-
-
Idaho
-
Boise, Idaho, United States, 83706
- Recruiting
- St. Alphonsus Regional Medical Center
-
Principal Investigator:
- Robert Farivar, MD
-
Contact:
- Joy Furlipa
- Email: Joy.Furlipa@saintalphonsus.org
-
-
Illinois
-
Chicago, Illinois, United States, 60640
- Active, not recruiting
- Rush University Medical Center
-
Oak Lawn, Illinois, United States, 60453
- Recruiting
- Advocate Christ Medical Center
-
Principal Investigator:
- Ravi Ramana, M.D.
-
Contact:
- Colleen Gallagher
- Email: Colleen.Gallagher@aah.org
-
Springfield, Illinois, United States, 62701
- Recruiting
- Prairie Education & Research Cooperative
-
Contact:
- Stephanie Hudson
- Email: shudson@prairieresearch.com
-
Principal Investigator:
- Jeffrey Goldstein, M.D.
-
-
Indiana
-
Indianapolis, Indiana, United States, 46260
- Recruiting
- St. Vincent Hospital
-
Contact:
- Hannah Willard
- Email: hannah.jenkins1@ascension.org
-
Principal Investigator:
- Sina Moainie, M.D.
-
-
Kansas
-
Wichita, Kansas, United States, 67226
- Recruiting
- Cardiovascular Research Institute of Kansas
-
Contact:
- Meredith Thunberg
- Email: Meredith.thunberg@cckheart.com
-
Principal Investigator:
- Bassem Chehab, M.D.
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- Recruiting
- University of Maryland Medical Center
-
Principal Investigator:
- Bradley Taylor, M.D.
-
Contact:
- Marcelina Puc
- Email: mpuc@som.umaryland.edu
-
Baltimore, Maryland, United States, 21218
- Recruiting
- MedStar Health Research Institute
-
Principal Investigator:
- Brian Bethea, M.D.
-
Contact:
- Keith Moyer
- Email: keith.t.moyer@medstar.net
-
Silver Spring, Maryland, United States, 20904
- Terminated
- Adventist Healthcare White Oak Medical Center
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Withdrawn
- Beth Israel Deaconess Medical Center
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- Recruiting
- University of Michigan
-
Principal Investigator:
- Matthew Romano, M.D.
-
Sub-Investigator:
- Gorav Ailawadi, M.D.
-
Contact:
- Allison Schley
- Email: schleya@med.umich.edu
-
Detroit, Michigan, United States, 48202
- Recruiting
- Henry Ford Hospital
-
Contact:
- Danielle Holmes
- Email: dholmes7@hfhs.org
-
Principal Investigator:
- Tiberio Frisoli, M.D.
-
Royal Oak, Michigan, United States, 48073
- Withdrawn
- Beaumont Hospital
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55407
- Recruiting
- Abbott Northwestern Hospital
-
Principal Investigator:
- Paul Sorajja, M.D.
-
Contact:
- Jennifer Nguyen
- Email: jennifer.nguyen@allina.com
-
Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic
-
Contact:
- Carl Griffin II
- Email: GriffinII.carl@mayo.edu
-
Principal Investigator:
- Mayra Guerrero, MD
-
-
Missouri
-
Kansas City, Missouri, United States, 64111
- Recruiting
- St. Luke's Hospital
-
Contact:
- Amber Ramsey
- Email: ambramsey1@saint-lukes.org
-
Principal Investigator:
- Keith Allen, M.D.
-
Saint Louis, Missouri, United States, 63110
- Active, not recruiting
- St. Louis University Hospital
-
-
Montana
-
Missoula, Montana, United States, 59802
- Recruiting
- The International Heart Institute of Montana
-
Contact:
- Christina Michael
- Email: Christina.Michael@providence.org
-
Principal Investigator:
- James Maddux, M.D.
-
-
New Hampshire
-
Manchester, New Hampshire, United States, 03102
- Active, not recruiting
- Catholic Medical Center
-
-
New Jersey
-
Hackensack, New Jersey, United States, 07601
- Recruiting
- Hackensack University Medical Center
-
Contact:
- Manuel Castillo
- Email: manuel.castillo@hmhn.org
-
Principal Investigator:
- Ryan Kaple, M.D.
-
New Brunswick, New Jersey, United States, 08901
- Recruiting
- Robert Wood Johnson University Hospital
-
Contact:
- Meghan Smith
- Email: ms3008@rwjms.rutgers.edu
-
Principal Investigator:
- Mark Russo, M.D.
-
Newark, New Jersey, United States, 07112
- Recruiting
- Newark Beth Israel Medical Center
-
Principal Investigator:
- Arash Salemi, M.D.
-
Contact:
- Patricia Policastro
- Email: Patricia.Policastro@rwjbh.org
-
-
New York
-
Albany, New York, United States, 12208
- Recruiting
- Albany Medical College at Albany Medical Center
-
Contact:
- Rebecca Belenchia
- Email: belencr@amc.edu
-
Principal Investigator:
- Sanjay Samy, M.D.
-
Bay Shore, New York, United States, 11706
- Recruiting
- Southside Hospital- Northwell Health
-
Principal Investigator:
- Robert Kalimi, M.D.
-
Contact:
- Samantha Annunziato
- Email: sannunziato@northwell.edu
-
Buffalo, New York, United States, 14203
- Recruiting
- Buffalo General Hospital
-
Principal Investigator:
- Vijay Iyer, M.D.
-
Contact:
- Kennedy Whitley
- Email: kwhitley@buffalo.edu
-
New York, New York, United States, 10075
- Recruiting
- Lenox Hill Hospital
-
Principal Investigator:
- Robert Kalimi, M.D.
-
Contact:
- Efstathia Mihelis
- Email: EMihelis@northwell.edu
-
Sub-Investigator:
- Chad Kliger, M.D.
-
New York, New York, United States, 10065
- Recruiting
- New York Presbyterian Hospital/ Weill Cornell Medical Center
-
Contact:
- Marshagay Rodriques
- Email: mar4028@med.cornell.edu
-
Principal Investigator:
- Stephanie Mick, M.D.
-
-
North Carolina
-
Asheville, North Carolina, United States, 28801
- Recruiting
- Mission Health & Hospitals
-
Principal Investigator:
- Mark Groh, M.D.
-
Contact:
- Christina Riggsbee
- Email: christina.riggsbee@hcahealthcare.com
-
Charlotte, North Carolina, United States, 28203
- Recruiting
- Carolinas Medical Center
-
Principal Investigator:
- Michael Rinaldi, M.D.
-
Contact:
- Montana Bright
- Email: montana.bright@atriumhealth.org
-
Charlotte, North Carolina, United States, 28204
- Recruiting
- Novant Health Heart and Vascular Research Institute
-
Contact:
- Amy Clontz
- Email: aclontz@novanthealth.org
-
Principal Investigator:
- Oluseun Alli, M.D.
-
-
Ohio
-
Cincinnati, Ohio, United States, 45219
- Recruiting
- University of Cincinnati Medical Center
-
Contact:
- Rachael Mardis
- Email: mardisrl@ucmail.uc.edu
-
Principal Investigator:
- Imran Arif, MD
-
Cleveland, Ohio, United States, 44195
- Recruiting
- The Cleveland Clinic Foundation
-
Principal Investigator:
- Samir Kapadia, M.D.
-
Contact:
- Madelyn Espen
- Email: espenm@ccf.org
-
-
Oklahoma
-
Tulsa, Oklahoma, United States, 74104
- Recruiting
- Oklahoma Heart Institute at Utica
-
Principal Investigator:
- Kamran Muhammad, M.D.
-
Contact:
- Linda Lor
- Email: linda.lor@oklahomaheart.com
-
-
Oregon
-
Portland, Oregon, United States, 97225
- Recruiting
- Providence Heart & Vascular Institute
-
Contact:
- Sarah Jackson
- Email: Sarah.Jackson3@providence.org
-
Principal Investigator:
- Brandon Jones, M.D.
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15232
- Recruiting
- UPMC Shadyside
-
Contact:
- Melissa Sanders Linger
- Email: sanderslingerm@upmc.edu
-
Principal Investigator:
- Anson Smith, M.D.
-
Pittsburgh, Pennsylvania, United States, 15212
- Recruiting
- Alleghany General Hospital - ASRI
-
Contact:
- Tracy Spirk
- Email: tracy.spirk@ahn.org
-
Principal Investigator:
- Walter McGregor, M.D.
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Recruiting
- Medical University of South Carolina
-
Principal Investigator:
- Marc Katz, M.D.
-
Contact:
- Stephanie Schorr
- Email: schorr@musc.edu
-
-
Tennessee
-
Memphis, Tennessee, United States, 38120
- Recruiting
- Baptist Memorial Hospital
-
Contact:
- Leigh Jackson
- Email: leigh.jackson@sterncardio.com
-
Principal Investigator:
- Basil Paulus, M.D.
-
Nashville, Tennessee, United States, 37203
- Recruiting
- Centennial Medical Center
-
Contact:
- Lauren Bozarth
- Email: lauren.bozarth@sarahcannon.com
-
Principal Investigator:
- Sreekumar Subramanian, M.D.
-
Nashville, Tennessee, United States, 37205
- Recruiting
- St. Thomas Hospital
-
Contact:
- Nikole Gasaway
- Email: nikole.minnick@ascension.org
-
Principal Investigator:
- Evelio Rodriguez, M.D.
-
-
Texas
-
Austin, Texas, United States, 78756
- Recruiting
- Cardiothoracic & Vascular Surgeons
-
Contact:
- Marcedes Coffman
- Email: MCoffman@ctvstexas.com
-
Principal Investigator:
- Faraz Kerendi, M.D.
-
Dallas, Texas, United States, 75230
- Active, not recruiting
- Medical City Dallas Hospital
-
Dallas, Texas, United States, 75226
- Recruiting
- Baylor Scott & White Heart and Vascular Hospital
-
Contact:
- Susan Aston
- Email: Susan.Aston@BSWHealth.org
-
Principal Investigator:
- Robert Hebeler, M.D.
-
Houston, Texas, United States, 77030
- Recruiting
- Memorial Hermann Hospital
-
Principal Investigator:
- Sukhdeep Basra, M.D.
-
Contact:
- Amber Li
- Email: amber.p.li@uth.tmc.edu
-
-
Virginia
-
Charlottesville, Virginia, United States, 22908
- Recruiting
- University of Virginia Medical Center
-
Principal Investigator:
- David Lim, M.D.
-
Contact:
- Kristen Determan, RN
- Email: XAS6FC@uvahealth.org
-
Falls Church, Virginia, United States, 22042
- Active, not recruiting
- Inova Fairfax Hospital
-
-
Washington
-
Seattle, Washington, United States, 98122
- Recruiting
- Swedish Medical Center - Heart & Vascular
-
Principal Investigator:
- Sameer Gafoor, M.D.
-
Contact:
- Michelle Garcia
- Email: michelle.garcia@swedish.org
-
-
West Virginia
-
Morgantown, West Virginia, United States, 26506
- Recruiting
- West Virginia University
-
Contact:
- Joshua Bombard
- Email: josh.bombard@wvumedicine.org
-
Principal Investigator:
- Vinay Badhwar, M.D.
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States, 53226
- Terminated
- Medical College of Wisconsin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Symptomatic, moderate-to-severe or severe mitral regurgitation, or severe mitral annular calcification (MAC)
- NYHA Functional Classification ≥ II (if Class IV, patient must be ambulatory)
- The local site heart team determines that the subject has been adequately treated per applicable standards
- Not a member of a vulnerable population
Exclusion Criteria:
- Mitral valvular vegetation or mass
- Left ventricular ejection fraction < 25%
- Left ventricular end diastolic diameter > 7.0 cm
- Prior surgical or interventional treatment of mitral valve involving implantation of prosthetic material
- Aortic valve disease requiring surgery or transcatheter intervention
- Severe tricuspid regurgitation or any tricuspid valve disease requiring surgery or transcatheter intervention
- Any planned surgical / interventional procedure within 60 day prior to or following subject randomization
- Subject undergoing hemodialysis due to chronic renal failure
- Mitral pathoanatomy and left ventricular outflow tract anatomy deemed not suitable for Trial device implantation
- Subjects with non-cardiac comorbidities that are likely to result in a life expectancy of less than 12 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Randomized Cohort - Treatment Group
Treatment of mitral regurgitation with the Tendyne Transcatheter Mitral Valve System
|
Mitral valve replacement
|
Active Comparator: Randomized Cohort - Control Group
Treatment of mitral regurgitation within commercially approved MitraClip system indications
|
Percutaneous mitral valve repair using the MitraClip system.
|
Experimental: Non-repairable Cohort
Treatment of mitral regurgitation with the Tendyne Transcatheter Mitral Valve System
|
Mitral valve replacement
|
Experimental: Severe Mitral Annular Calcification (MAC) Cohort
Treatment of mitral regurgitation and mitral annular calcification with the Tendyne Transcatheter Mitral Valve System
|
Mitral valve replacement
|
Experimental: Severe Mitral Annular Calcification Continued Access Protocol (MAC CAP) Cohort
Treatment of mitral regurgitation and mitral annular calcification with the Tendyne Transcatheter Mitral Valve System after the completion of enrollment in the Severe MAC Cohort
|
Mitral valve replacement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Randomized Cohort
Time Frame: 1 year
|
Survival free of heart failure hospitalization at 12 months post index procedure
|
1 year
|
Non-repairable Cohort
Time Frame: 1 year
|
Survival free of heart failure hospitalization at 12 months post index procedure
|
1 year
|
Severe Mitral Annular Calcification (MAC) Cohort
Time Frame: 1 year
|
Survival free of heart failure hospitalization at 12 months post index procedure
|
1 year
|
Severe MAC Continued Access Protocol (MAC CAP) Cohort
Time Frame: 1 year
|
Survival free of heart failure hospitalization at 12 months post index procedure
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in distance walked, as measured by the 6 Minute Walk Test (6MWT)
Time Frame: 1 year
|
1 year
|
Change from baseline in quality of life, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time Frame: 1 year
|
1 year
|
Change from baseline in health outcomes, as measured by the EQ-5D
Time Frame: 1 year
|
1 year
|
• Change from baseline in health outcomes, as measured by the 12-item Short Form Health Survey (SF-12)
Time Frame: 1 year
|
1 year
|
Change from baseline in New York Heart Association Classification
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ryan Palmer, PhD, Abbott Structural Heart
- Principal Investigator: Gorav Ailawadi, MD, University of Michigan
- Principal Investigator: Jason Rogers, MD, University of California, Davis
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CS0004-P
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Hangzhou Valgen Medtech Co., LtdNot yet recruitingMitral Valve Insufficiency
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Southern Illinois UniversityWithdrawnMyocardial Infarction | Mitral RegurgitationUnited States
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Neovasc Inc.Active, not recruitingMitral Valve RegurgitationUnited States, Canada, Belgium
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Meshalkin Research Institute of Pathology of CirculationCompletedHypertrophic Obstructive CardiomyopathyRussian Federation