The TRICURE EU Pivotal Study

Launched by TRICARES · Aug 26, 2024

Keywords

ClinConnect Summary

The TRICURE EU Pivotal 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 is specifically focused on patients who have severe tricuspid valve regurgitation, a condition where the heart's tricuspid valve does not close properly, leading to poor blood flow. If you're an adult between the ages of 65 and 74 and have been evaluated by a specialized heart team as being at increased risk for traditional surgery, you might be eligible to participate.

If you join the trial, you will receive close medical monitoring and care throughout the study. The researchers aim to gather important information about how well this new valve replacement system works and how safe it is for patients like you. It's important to note that this study is not for those who need immediate treatment, have unstable heart conditions, or certain anatomical issues that would prevent the device from being implanted. The trial is currently recruiting participants, and your involvement could help advance treatment options for heart valve disease.

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