This study is in progress, not accepting new patients

New Investigational Device Study for Tricuspid Valve Replacement

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a study on Tricuspid Valve Regurgitation Tricuspid Valve Insufficiency Tricuspid Valve Disease Heart Valve Disease Cardiovascular Disease Heart Failure

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis UCSF
Dates
study started
completion around

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

Locations

  • UC Davis Medical Center
    Sacramento California 95817 United States
  • University of California San Francisco
    San Francisco California 94143 United States
  • Kaiser Permanente San Francisco
    San Francisco California 94118 United States
  • Scripps Memorial Hospital La Jolla
    La Jolla California 92037 United States
  • Cedars-Sinai Medical Center
    Los Angeles California 90048 United States
  • Stanford University
    Stanford California 94305 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Edwards Lifesciences
ID
NCT04482062
Study Type
Interventional
Participants
Expecting 1070 study participants
Last Updated