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Active, currently enrolling

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

NCT No.: NCT04482062

Study Type: INTERVENTIONAL

Phase: n/a

Region: California - Northern

Acronym: 

Official Title

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

Purpose

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

Detailed Description

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.

Sex

Male & Female

Age Limit

18 years & older

Eligibility Criteria

Inclusion Criteria

Symptomatic tricuspid regurgitation (TR) despite medical therapy

TR graded as severe or greater

Appropriate for transcatheter tricuspid valve replacement per the local heart team

Exclusion Criteria

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

Keywords and/or Specific Medical Conditions

  • 2020-05
  • Cardiovascular Diseases
  • Heart Diseases
  • Heart Valve Diseases
  • Tricuspid Valve Insufficiency
  • Cardiology

Sponsors

  • Edwards Lifesciences

Clinical Area

  • Cardiology

Principal Investigator

Andrew Rassi , MD 

Contact Information

 - CTP Team
- CTPCollaborate@kp.org
- San Francisco Medical Center

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