Early Phase Study Using the 'Pivot Extend' System as a Treatment for Patients With Tricuspid Regurgitation

Participants with severe tricuspid regurgitation may require heart surgery to repair or replace the tricuspid valve. However, there is a high risk associated with these surgeries and it is often not feasible for elderly patients or those with other medical conditions. The goal of this clinical investigation is * To assess the safety of the investigational device "Pivot Extend" in participants aged 18 years or over with severe and clinically symptomatic Tricuspid Regurgitation (TR) deemed suitable for percutaneous valve intervention * To evaluate device success, procedural success and clinical outcomes in improving TR symptoms following implantation of the "Pivot Extend" device

NCT Number	NCT07172477
Lead Sponsor	Tau Medical Australia Pty Ltd Collaborators: Tau-MEDICAL Co., Ltd.
Conditions	Tricuspid Regurgitation
Enrollment	10 participants
Start Date	2025-11-11
Primary Completion	2026-04 (estimated)
Study Completion	2027-03 (estimated)
Updated on ClinicalTrials.gov	2025-12-09