Trial Search Results

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

Prospective, controlled, multicenter clinical investigation with three trial cohorts: Randomized, Non-Randomized, and Mitral Annular Calcification (MAC). 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-Randomized and MAC cohorts will receive the trial device.

The objective of the Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) is to evaluate the safety and effectiveness of the Tendyne 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 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 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-randomized cohort.

Subjects will be seen at screening, pre- and post-procedure, discharge, 30 days, 3 months, 6 months, and annually through 5 years.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Abbott Medical Devices

Intervention(s):

  • Device: Tendyne Mitral Valve System
  • Device: MitraClip System

Phase:

N/A

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting