Clinical Evidence

TRiCares is conducting clinical trials investigating the feasibility, safety and performance of the Topaz Transcatheter Tricuspid Valve Replacement (TTVR) system. Topaz is designed to eliminate tricuspid regurgitation (TR) through a minimally invasive approach.

View our active and completed clinical trials below:

Active Studies (Enrollment completed):

TRICURE FIH (first-in-human) Trial (NCT05126030)

Topaz has been evaluated for safety and feasibility in a first-in-human study, with results presented at EuroPCR in May 2025. Patients are currently in follow-up for up to 5 years.

Learn more here: [Study Details | The TRICURE First in Human Trial | ClinicalTrials.gov]

Ongoing Studies (Recruiting):

TRICURE European Pivotal Study (NCT06581471)

This pivotal study will assess the safety and performance of Topaz in patients with significant TR who are identified with increased operative risk. The study is taking place at leading clinical sites across Europe.

For more information on our ongoing European Pivotal Trial visit: [Study Details | The TRICURE EU Pivotal Study | ClinicalTrials.gov]

Ongoing Studies (Recruiting):

TRICURE US Early Feasibility Study (NCT06506942)

Approved under a Food and Drug Administration Investigational Drug Exemption, this study will assess the safety and performance of Topaz in adult patients with severe TR who are identified with increased operative risk. The study is enrolling patients in specialist sites across the US and Canada.

For more information on our US EFS trial visit: [Study Details | The TRICURE EFS Study | ClinicalTrials.gov]