Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation
- Conditions
- Mitral RegurgitationMitral Valve InsufficiencyMitral InsufficiencyCardiovascular DiseasesValve Disease, HeartFunctional Mitral RegurgitationDegenerative Mitral Valve DiseaseHeart Valve Diseases
- Interventions
- Device: Tendyne Mitral Valve SystemDevice: MitraClip System
- Registration Number
- NCT03433274
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 958
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Randomized Cohort - Treatment Group Tendyne Mitral Valve System Treatment of mitral regurgitation with the Tendyne Transcatheter Mitral Valve System Randomized Cohort - Control Group MitraClip System Treatment of mitral regurgitation within commercially approved MitraClip system indications Non-repairable Cohort Tendyne Mitral Valve System Treatment of mitral regurgitation with the Tendyne Transcatheter Mitral Valve System Severe Mitral Annular Calcification (MAC) Cohort Tendyne Mitral Valve System Treatment of mitral regurgitation and mitral annular calcification with the Tendyne Transcatheter Mitral Valve System Severe Mitral Annular Calcification Continued Access Protocol (MAC CAP) Cohort Tendyne Mitral Valve System 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
- Primary Outcome Measures
Name Time Method Severe Mitral Annular Calcification (MAC) Cohort 1 year Survival free of heart failure hospitalization at 12 months post index procedure
Randomized Cohort 1 year Survival free of heart failure hospitalization at 12 months post index procedure
Severe MAC Continued Access Protocol (MAC CAP) Cohort 1 year Survival free of heart failure hospitalization at 12 months post index procedure
Non-repairable Cohort 1 year Survival free of heart failure hospitalization at 12 months post index procedure
- Secondary Outcome Measures
Name Time Method Change from baseline in New York Heart Association Classification 1 year • Change from baseline in health outcomes, as measured by the 12-item Short Form Health Survey (SF-12) 1 year Change from baseline in quality of life, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) 1 year Change from baseline in distance walked, as measured by the 6 Minute Walk Test (6MWT) 1 year Change from baseline in health outcomes, as measured by the EQ-5D 1 year
Trial Locations
- Locations (80)
MedStar Health Research Institute
🇺🇸Balitmore, Maryland, United States
South Shore University Hospital
🇺🇸Bay Shore, New York, United States
West Virginia University Hospital
🇺🇸Morgantown, West Virginia, United States
Institut de Cardiologie de Montreal (Montreal Heart Institute)
🇨🇦Montréal, Quebec, Canada
Princeton Baptist Medical Center
🇺🇸Birmingham, Alabama, United States
UAB University Hospital
🇺🇸Birmingham, Alabama, United States
Banner-University Medical Center
🇺🇸Phoenix, Arizona, United States
HonorHealth Scottsdale Shea Medical Center
🇺🇸Scottsdale, Arizona, United States
Baptist Health Medical Center
🇺🇸Little Rock, Arkansas, United States
Fresno Heart Hospital
🇺🇸Fresno, California, United States
University of Southern California University Hospital
🇺🇸Los Angeles, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Sutter Medical Center, Sacramento
🇺🇸Sacramento, California, United States
University of California - Davis Medical Center
🇺🇸Sacramento, California, United States
San Diego Cardiac Center
🇺🇸San Diego, California, United States
University of California at San Francisco
🇺🇸San Francisco, California, United States
Stanford Health Care
🇺🇸Stanford, California, United States
Los Robles Hospital and Medical Center
🇺🇸Thousand Oaks, California, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
Manatee Memorial Hospital
🇺🇸Bradenton, Florida, United States
Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
Delray Medical Center
🇺🇸Delray Beach, Florida, United States
North Florida Regional Medical Center
🇺🇸Gainesville, Florida, United States
Shands at the University of Florida
🇺🇸Gainesville, Florida, United States
Baptist Hospital of Miami
🇺🇸Miami, Florida, United States
Tallahassee Research Institute
🇺🇸Tallahassee, Florida, United States
Cleveland Clinic Florida
🇺🇸Weston, Florida, United States
Piedmont Heart Institute
🇺🇸Atlanta, Georgia, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Wellstar Kennestone Hospital
🇺🇸Marietta, Georgia, United States
St. Alphonsus Regional Medical Center
🇺🇸Boise, Idaho, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Advocate Christ Medical Center
🇺🇸Oak Lawn, Illinois, United States
Prairie Education & Research Cooperative
🇺🇸Springfield, Illinois, United States
St. Vincent Hospital
🇺🇸Indianapolis, Indiana, United States
Cardiovascular Research Institute of Kansas
🇺🇸Wichita, Kansas, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Adventist HealthCare White Oak Medical Center
🇺🇸Silver Spring, Maryland, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Abbott Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
St. Luke's Hospital
🇺🇸Kansas City, Missouri, United States
St. Louis University Hospital
🇺🇸Saint Louis, Missouri, United States
The International Heart Institute of Montana
🇺🇸Missoula, Montana, United States
Catholic Medical Center
🇺🇸Manchester, New Hampshire, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Robert Wood Johnson University Hospital
🇺🇸New Brunswick, New Jersey, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
Albany Medical College at Albany Medical Center
🇺🇸Albany, New York, United States
Buffalo General Hospital
🇺🇸Buffalo, New York, United States
New York Presbyterian Hospital/ Weill Cornell Medical Center
🇺🇸New York, New York, United States
Lenox Hill Hospital
🇺🇸New York, New York, United States
Mission Health & Hospitals
🇺🇸Asheville, North Carolina, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Novant Health Heart and Vascular Research Institute
🇺🇸Charlotte, North Carolina, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Oklahoma Heart Institute at Utica
🇺🇸Tulsa, Oklahoma, United States
Providence Heart & Vascular Institute
🇺🇸Portland, Oregon, United States
Allegheny General Hospital - ASRI
🇺🇸Pittsburgh, Pennsylvania, United States
UPMC Shadyside
🇺🇸Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Baptist Memorial Hospital
🇺🇸Memphis, Tennessee, United States
Centennial Medical Center
🇺🇸Nashville, Tennessee, United States
St. Thomas Hospital
🇺🇸Nashville, Tennessee, United States
Cardiothoracic & Vascular Surgeons
🇺🇸Austin, Texas, United States
Baylor Scott & White Heart and Vascular Hospital
🇺🇸Dallas, Texas, United States
Medical City Dallas Hospital
🇺🇸Dallas, Texas, United States
Memorial Hermann Hospital
🇺🇸Houston, Texas, United States
University of Virginia Medical Center
🇺🇸Charlottesville, Virginia, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Swedish Medical Center - Heart & Vascular
🇺🇸Seattle, Washington, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Ottawa Heart Institute
🇨🇦Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
The Royal Victoria Hospital
🇨🇦Montreal, Quebec, Canada