Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT)

January 24, 2024 updated by: Abbott Medical Devices

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

Study Type

Interventional

Enrollment (Estimated)

958

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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:
        • Principal Investigator:
          • Mustafa Ahmed, M.D.
    • Arizona
      • Phoenix, Arizona, United States, 85006
      • Scottsdale, Arizona, United States, 85260
        • Recruiting
        • HonorHealth Scottsdale Shea Medical Center
        • Contact:
        • Principal Investigator:
          • David Rizik, M.D.
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • California
      • Fresno, California, United States, 93720
        • Active, not recruiting
        • Fresno Heart Hospital
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Contact:
        • 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:
      • 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:
      • 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:
      • Thousand Oaks, California, United States, 91360
        • Recruiting
        • Los Robles Hospital and Medical Center
        • Contact:
        • 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:
        • 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:
      • 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:
        • Principal Investigator:
          • Thomas Noel, M.D.
      • Weston, Florida, United States, 33331
        • Recruiting
        • Cleveland Clinic Florida
        • Principal Investigator:
          • Samir Kapadia, M.D.
        • Contact:
        • Sub-Investigator:
          • Mauricio Cohen, M.D.
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital
        • Contact:
        • Principal Investigator:
          • Vasilis Babaliaros, M.D.
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Piedmont Heart Institute
        • Contact:
        • 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:
    • Idaho
      • Boise, Idaho, United States, 83706
        • Recruiting
        • St. Alphonsus Regional Medical Center
        • Principal Investigator:
          • Robert Farivar, MD
        • Contact:
    • 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:
      • Springfield, Illinois, United States, 62701
        • Recruiting
        • Prairie Education & Research Cooperative
        • Contact:
        • Principal Investigator:
          • Jeffrey Goldstein, M.D.
    • Indiana
      • Indianapolis, Indiana, United States, 46260
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Recruiting
        • Cardiovascular Research Institute of Kansas
        • Contact:
        • 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:
      • Baltimore, Maryland, United States, 21218
        • Recruiting
        • MedStar Health Research Institute
        • Principal Investigator:
          • Brian Bethea, M.D.
        • Contact:
      • 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:
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
        • Contact:
        • 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:
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Mayra Guerrero, MD
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • St. Luke's Hospital
        • Contact:
        • 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:
        • 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:
        • Principal Investigator:
          • Ryan Kaple, M.D.
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Robert Wood Johnson University Hospital
        • Contact:
        • 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:
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Albany Medical College at Albany Medical Center
        • Contact:
        • 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:
      • Buffalo, New York, United States, 14203
        • Recruiting
        • Buffalo General Hospital
        • Principal Investigator:
          • Vijay Iyer, M.D.
        • Contact:
      • New York, New York, United States, 10075
        • Recruiting
        • Lenox Hill Hospital
        • Principal Investigator:
          • Robert Kalimi, M.D.
        • Contact:
        • Sub-Investigator:
          • Chad Kliger, M.D.
      • New York, New York, United States, 10065
        • Recruiting
        • New York Presbyterian Hospital/ Weill Cornell Medical Center
        • Contact:
        • Principal Investigator:
          • Stephanie Mick, M.D.
    • North Carolina
      • Asheville, North Carolina, United States, 28801
      • Charlotte, North Carolina, United States, 28203
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Novant Health Heart and Vascular Research Institute
        • Contact:
        • Principal Investigator:
          • Oluseun Alli, M.D.
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Medical Center
        • Contact:
        • Principal Investigator:
          • Imran Arif, MD
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • The Cleveland Clinic Foundation
        • Principal Investigator:
          • Samir Kapadia, M.D.
        • Contact:
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Recruiting
        • Oklahoma Heart Institute at Utica
        • Principal Investigator:
          • Kamran Muhammad, M.D.
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Heart & Vascular Institute
        • Contact:
        • Principal Investigator:
          • Brandon Jones, M.D.
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • UPMC Shadyside
        • Contact:
        • Principal Investigator:
          • Anson Smith, M.D.
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Alleghany General Hospital - ASRI
        • Contact:
        • 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:
    • Tennessee
      • Memphis, Tennessee, United States, 38120
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Centennial Medical Center
        • Contact:
        • Principal Investigator:
          • Sreekumar Subramanian, M.D.
      • Nashville, Tennessee, United States, 37205
    • Texas
      • Austin, Texas, United States, 78756
        • Recruiting
        • Cardiothoracic & Vascular Surgeons
        • Contact:
        • 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:
        • Principal Investigator:
          • Robert Hebeler, M.D.
      • Houston, Texas, United States, 77030
        • Recruiting
        • Memorial Hermann Hospital
        • Principal Investigator:
          • Sukhdeep Basra, M.D.
        • Contact:
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia Medical Center
        • Principal Investigator:
          • David Lim, M.D.
        • Contact:
      • 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:
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University
        • Contact:
        • Principal Investigator:
          • Vinay Badhwar, M.D.
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Terminated
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2018

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

February 8, 2018

First Submitted That Met QC Criteria

February 8, 2018

First Posted (Actual)

February 14, 2018

Study Record Updates

Last Update Posted (Actual)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • CS0004-P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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