Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) (the "trial")
Prospective, controlled, multicenter clinical investigation of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe mitral regurgitation Subjects will be assigned to either a surgical or a non-surgical arm, at the discretion of the local site heart team. Subjects must satisfy the trial inclusion/exclusion criteria, and be approved by the Subject Eligibility Committee (SEC), prior to inclusion in the trial. Surgical arm: Subjects whom the local site heart team determines are appropriate for mitral valve surgery will be randomized in a 2:1 ratio to the Tendyne device (Treatment group) or to standard of care surgical repair or total chordal-sparing surgical replacement (Control group). Randomization will be stratified by investigational site. Non-surgical arm: Subjects whom the local site heart team determines are not appropriate for mitral valve surgery and whose valve anatomy is not suitable for transcatheter repair, will be eligible to enroll into the non-surgical arm in which all subjects will receive the Tendyne device.
MoreAdult
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)
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
Treatment
University of Colorado Hospital
Aken Desai, MD
Protocol Number: 18-0505
More information available at ClinicalTrials.gov: NCT03433274
Is this Study for You?
Not finding the right Study for you? Join ResearchMatch, a nation-wide registry connecting volunteers and researchers