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.More
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)
Detailed Eligibility: 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
III - Research Studies that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.
University of Colorado Hospital
John Carroll, MD
Protocol Number: 18-0505
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