Clinical Trial

The TRICURE First in Human Trial

Study acronym: TRICURE
Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
The objective of this first in human study is to gain early clinical insight into the safety profile and performance of the Topaz transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2021-11-17; most recent amendment 2025-03-21.
Status change: Recruiting → Active, Not Recruiting 2025-03-21
Status change: Not Yet Recruiting → Recruiting 2022-07-30
Trial Details
NCT Number NCT05126030
Lead Sponsor TRiCares
Conditions Tricuspid Regurgitation
Enrollment 20 participants
Start Date 2022-07-15
Primary Completion 2025-03-01 (estimated)
Study Completion 2029-05-15 (estimated)
Updated on ClinicalTrials.gov 2025-03-26