Early Feasibility of 'Pivot Extend' for Tricuspid Regurgitation Treatment

This clinical trial aims to evaluate the safety and demonstrate the efficacy of treatment to improve tricuspid regurgitation (TR) symptoms in patients with severe and clinically symptomatic TR through long-term implantation of an investigational medical device. 1. Determine the safety of long-term implantation of the investigational medical device "Pivot Extend" by monitoring for MACEs associated with the investigational medical device or procedure that may occur with long-term associated with the investigational medical device or procedure that may occur with long-term implantation. 2. Device success, procedural success, and clinical outcomes of long-term implantation of the investigational medical device "Pivot Extend" will be monitored.

NCT Number	NCT06877520
Lead Sponsor	Tau-MEDICAL Co., Ltd.
Conditions	Tricuspid Regurgitation (TR)
Enrollment	7 participants
Start Date	2025-05
Primary Completion	2026-05 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2025-04-11