TRISCEND II Pivotal Trial

• Status: Recruiting
• Trial end date: 2028-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Edwards Lifesciences

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