Early Feasibility Study of the Edwards Tricuspid Transcatheter Repair System

Description

The early feasibility study of the Edwards Tricuspid Transcatheter Repair System is a multi-center, prospective, early feasibility study to evaluate the safety and function of the Edwards Tricuspid Transcatheter Repair System.

Study Start Date

July 2015

Estimated Completion Date

January 2019

Interventions

  • Device: EW Transcatheter Tricuspid Repair System

Specialties

  • Cardiology: Valvular Disease
  • Internal Medicine: Cardiology
  • Physician Assistant: Cardiology

MeSH Terms

  • Cardiovascular Diseases
  • Heart Diseases
  • Heart Valve Diseases
  • Tricuspid Valve Insufficiency

Study ID

Edwards Lifesciences -- 2014-04

Status

Unknown

Trial ID

NCT02471807

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

15

Sponsor

Edwards Lifesciences

Inclusion Criteria

    1. Clinically significant, symptomatic, functional or secondary, tricuspid regurgitation (per applicable guidelines) requiring tricuspid valve repair or replacement as assessed by the Heart Team 2. NYHA Functional Class III or greater 3. Determined by the 'HEART Team' (a minimum of one Cardiologist, and one Cardiac Surgeon) to be at high surgical risk for tricuspid valve repair or replacement

Exclusion Criteria

    See Protocol

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (3)

Study Location Distance Name Phone Email
Columbia University Medical Center - New York, New York 44.8 miles Kate Dalton 212-342-1820 keb2114@cumc.columbia.edu
Emory University Hospital - Atlanta, Georgia 795.6 miles Lauren Wheeler 404-712-0131 lmwheeler@emory.edu
CedarsSinai Medical Center - Los Angeles, California 2,495.4 miles Rajendra Makkar Doctor of Medicine 310-423-3977 Raj.Makkar@cshs.org

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