TTVR STRONG Under Coverage With Evidence Development (CED) Study

Launched by EDWARDS LIFESCIENCES · Feb 13, 2025

Keywords

ClinConnect Summary

The TTVR STRONG study is looking at the long-term health effects of a specific heart procedure called Transcatheter Tricuspid Valve Replacement (TTVR) for patients with a serious heart condition known as Tricuspid Regurgitation. This condition means that the heart's tricuspid valve isn't working properly, causing blood to flow backward and leading to various symptoms. The study focuses on patients who have received or are eligible to receive the EVOQUE device, which is used in this procedure.

To be eligible for this trial, participants need to be Medicare patients who have severe Tricuspid Regurgitation. Unfortunately, patients with other types of insurance or those with less severe symptoms won't be able to participate. If you join the study, you'll help researchers understand how well the EVOQUE device works over time, which could lead to better treatments for others in the future. The trial is currently recruiting participants, and everyone involved will be monitored to gather important health information throughout the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Medicare eligible patients who have received an EVOQUE device or are EVOQUE eligible and have at least severe Tricuspid Regurgitation
• Exclusion Criteria:
• • Commercially insured patients who have received an EVOQUE device or are EVOQUE eligible or Medicare eligible patients with less than severe Tricuspid Regurgitation