2019-06 TRISCEND Study

Launched by EDWARDS LIFESCIENCES · Jan 6, 2020

Keywords

ClinConnect Summary

The TRISCEND Study is a clinical trial designed to evaluate the safety and effectiveness of a new treatment called the Edwards EVOQUE Tricuspid Valve Replacement System. This treatment aims to help patients who have moderate to severe tricuspid valve regurgitation, which is a condition where the heart's tricuspid valve does not close properly, leading to symptoms like shortness of breath and fatigue. The study is currently active but not recruiting new participants.

To be eligible for this trial, patients typically need to be between the ages of 65 and 74 and should have symptoms of tricuspid valve regurgitation that have not improved with standard medical treatments. They should also have experienced heart failure hospitalization due to this condition. However, patients with certain heart problems or those needing urgent surgery are not eligible. If someone qualifies and participates, they can expect to undergo a procedure that replaces the faulty valve with the new device, and their progress will be closely monitored throughout the study.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Functional or degenerative TR moderate or greater
• • Symptomatic despite medical therapy or prior HF hospitalization from TR
• • The Local Site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement
• Key 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