The TRICURE EFS Study

Launched by TRICARES · Jul 17, 2024

Keywords

ClinConnect Summary

The TRICURE EFS Study is a clinical trial designed to evaluate the safety and effectiveness of a new device called the TRiCares Topaz Tricuspid Valve Replacement System. This study focuses on patients with severe tricuspid valve regurgitation, which is a condition where the heart's tricuspid valve does not close properly, causing blood to flow backward. The trial is currently recruiting participants who are adults aged 65 to 74, and who have been assessed by a heart team as being at increased risk for surgery.

To be eligible for this study, patients must have severe tricuspid regurgitation, but they should not be in urgent need of surgery or experiencing unstable heart conditions. Participants can expect to undergo the procedure using this new valve replacement system and will be closely monitored to ensure their safety throughout the study. This trial is important because it aims to find better treatment options for patients with heart valve diseases, potentially improving their quality of life.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult patients
• • Tricuspid regurgitation grade 3 (severe) on a scale of 0 (none) to 5 (torrential)
• • Institutional Heart Team evaluates patient as being at increased operative risk
• Exclusion Criteria:
• • Patient in need of emergent intervention
• • Patient who is hemodynamically unstable
• • Anatomical contraindications for implantation with study device
• • Patient who is currently participating in another clinical investigation where the primary endpoint was not reached yet