Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT)
Mitral Regurgitation, Mitral Insufficiency, Mitral Valve Insufficiency
About this trial
This is an interventional treatment trial for Mitral Regurgitation
Eligibility Criteria
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
Sites / Locations
- Princeton Baptist Medical Center
- UAB University HospitalRecruiting
- Banner-University Medical CenterRecruiting
- HonorHealth Scottsdale Shea Medical CenterRecruiting
- Fresno Heart HospitalRecruiting
- University of Southern California University HospitalRecruiting
- Cedars-Sinai Medical CenterRecruiting
- Sutter Medical Center, SacramentoRecruiting
- University of California - Davis Medical CenterRecruiting
- San Diego Cardiac CenterRecruiting
- University of California at San FranciscoRecruiting
- Stanford Health CareRecruiting
- Los Robles Hospital and Medical CenterRecruiting
- University of Colorado Hospital
- Manatee Memorial HospitalRecruiting
- Morton Plant HospitalRecruiting
- Delray Medical Center
- North Florida Regional Medical CenterRecruiting
- Shands at the University of FloridaRecruiting
- Baptist Hospital of MiamiRecruiting
- Tallahassee Research InstituteRecruiting
- Cleveland Clinic FloridaRecruiting
- Piedmont Heart InstituteRecruiting
- Emory University HospitalRecruiting
- Wellstar Kennestone HospitalRecruiting
- St. Alphonsus Regional Medical CenterRecruiting
- Rush University Medical CenterRecruiting
- Advocate Christ Medical CenterRecruiting
- Prairie Education & Research CooperativeRecruiting
- St. Vincent HospitalRecruiting
- Cardiovascular Research Institute of KansasRecruiting
- University of Maryland Medical CenterRecruiting
- Medstar Health Research InstituteRecruiting
- Adventist HealthCare White Oak Medical Center
- Beth Israel Deaconess Medical CenterRecruiting
- University of MichiganRecruiting
- Henry Ford HospitalRecruiting
- Beaumont Hospital
- Abbott Northwestern HospitalRecruiting
- Mayo ClinicRecruiting
- St. Luke's HospitalRecruiting
- St. Louis University HospitalRecruiting
- The International Heart Institute of MontanaRecruiting
- Catholic Medical CenterRecruiting
- Hackensack University Medical CenterRecruiting
- Robert Wood Johnson University HospitalRecruiting
- Newark Beth Israel Medical CenterRecruiting
- Albany Medical College at Albany Medical CenterRecruiting
- Southside Hospital- Northwell HealthRecruiting
- Buffalo General HospitalRecruiting
- New York Presbyterian Hospital/ Weill Cornell Medical CenterRecruiting
- Lenox Hill HospitalRecruiting
- Mission Health & HospitalsRecruiting
- Carolinas Medical CenterRecruiting
- Novant Health Heart and Vascular Research InstituteRecruiting
- University of Cincinnati Medical CenterRecruiting
- The Cleveland Clinic FoundationRecruiting
- Oklahoma Heart Institute at UticaRecruiting
- Providence Heart & Vascular InstituteRecruiting
- Alleghany General Hospital - ASRIRecruiting
- UPMC ShadysideRecruiting
- Medical University of South CarolinaRecruiting
- Baptist Memorial HospitalRecruiting
- Centennial Medical CenterRecruiting
- St. Thomas HospitalRecruiting
- Cardiothoracic & Vascular SurgeonsRecruiting
- Baylor Scott & White Heart and Vascular HospitalRecruiting
- Medical City Dallas HospitalRecruiting
- Memorial Hermann HospitalRecruiting
- University of Virginia Medical CenterRecruiting
- Inova Fairfax HospitalRecruiting
- Swedish Medical Center - Heart & VascularRecruiting
- West Virginia UniversityRecruiting
- Medical College of Wisconsin
- Ottawa Heart InstituteRecruiting
- St. Michael's HospitalRecruiting
- Sunnybrook Health Sciences CentreRecruiting
- The Royal Victoria HospitalRecruiting
- Montreal Heart InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Active Comparator
Experimental
Experimental
Experimental
Randomized Cohort - Treatment Group
Randomized Cohort - Control Group
Non-repairable Cohort
Severe Mitral Annular Calcification (MAC) Cohort
Severe Mitral Annular Calcification Continued Access Protocol (MAC CAP) Cohort
Treatment of mitral regurgitation with the Tendyne Transcatheter Mitral Valve System
Treatment of mitral regurgitation within commercially approved MitraClip system indications
Treatment of mitral regurgitation with the Tendyne Transcatheter Mitral Valve System
Treatment of mitral regurgitation and mitral annular calcification with the Tendyne Transcatheter 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