Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Vaikom Mahadevan, MD
Photo of Vaikom Mahadevan
Vaikom Mahadevan

Description

Summary

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.

Keywords

Mitral Regurgitation Mitral Insufficiency Mitral Valve Insufficiency Cardiovascular Diseases Valve Disease, Heart Heart Valve Diseases Functional Mitral Regurgitation Degenerative Mitral Valve Disease Tendyne Mitral Valve System MitraClip System

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California at San Francisco accepting new patients
    San Francisco California 94143 United States
  • Fresno Heart Hospital accepting new patients
    Fresno California 93720 United States

Lead Scientist at UCSF

  • Vaikom Mahadevan, MD
    Dr. Vaikom S Mahadevan joined UCSF from the UK in July 2014 as Director of Structural and Adult Congenital cardiac Interventions and the Wiliam W Parmley Endowed Chair in Cardiology and Associate Professor of Medicine. Following completion of his intital medical training in Stanley Medical College in India Dr. Mahadevan did his higher Internal Medicine and Cardiology training …

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Abbott Medical Devices
ID
NCT03433274
Study Type
Interventional
Last Updated