Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system

Official Title

Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device

Details

The study is a prospective, multi-center, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the EVOQUE System with optimal medical therapy (OMT) compared to OMT alone in the treatment of patients with at least severe tricuspid regurgitation. Subjects will be followed at discharge, 30 days, 3 months, 6 months and annually through 5 years.

Keywords

Tricuspid Valve Regurgitation Tricuspid Valve Insufficiency Tricuspid Valve Disease Heart Valve Diseases Cardiovascular Diseases Heart Failure Edwards EVOQUE System Optimal Medical Therapy Edwards EVOQUE System & OMT

Eligibility

You can join if…

Open to people ages 18 years and up

  • Symptomatic tricuspid regurgitation (TR) despite medical therapy
  • TR graded as severe or greater
  • Appropriate for transcatheter tricuspid valve replacement per the local heart team

You CAN'T join if...

  • Tricuspid valve anatomic contraindications
  • Need for emergent or urgent surgery or any planned cardiac surgery within the next 12 months
  • Hemodynamic instability
  • Refractory heart failure requiring advanced intervention
  • Currently participating in another investigational study in which the patient has not reached a primary endpoint

Locations

  • Kaiser Permanente San Francisco accepting new patients
    San Francisco California 94118 United States
  • Stanford University accepting new patients
    Stanford California 94305 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Edwards Lifesciences
Links
Sign up for this study
ID
NCT04482062
Study Type
Interventional
Participants
Expecting 820 study participants
Last Updated