TRISCEND II Pivotal Trial

Not Recruiting

Trial ID: NCT04482062


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

Stanford Investigator(s)

Rahul P Sharma, MBBS, FRACP
Rahul P Sharma, MBBS, FRACP

Clinical Associate Professor, Medicine - Cardiovascular Medicine

Christiane Haeffele
Christiane Haeffele

Clinical Associate Professor, Medicine - Cardiovascular Medicine Clinical Assistant Professor, Pediatrics - Cardiology


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

   - Hemodynamic instability

   - Refractory heart failure requiring advanced intervention

   - Currently participating in another investigational study


device: Edwards EVOQUE System

drug: Optimal Medical Therapy

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305