RecruitingNot ApplicableNCT06877520

Early Feasibility of 'Pivot Extend' for Tricuspid Regurgitation Treatment

Early Feasibility Study (EFS) of the 'Pivot Extend' in Treatment for Tricuspid Regurgitation (SPACER Study)

Sponsor

Tau-MEDICAL Co., Ltd.

Enrollment

7 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

Tricuspid Regurgitation (TR)

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Pivot Extend Tricuspid Regurgitation Spacer Device for people with tricuspid regurgitation (tr). The study is currently recruiting participants at 3 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPivot Extend Tricuspid Regurgitation Spacer Device

The Pivot Extend Tricuspid Regurgitation Spacer Device is an investigational implant designed to reduce tricuspid regurgitation (TR) by occupying the regurgitant orifice and improving leaflet coaptation. The device is implanted via a transcatheter procedure under imaging guidance. Following implantation, participants will undergo post-procedural monitoring for at least 24 hours to ensure safety and device stability. The device is intended for long-term placement, with scheduled follow-up assessments at designated intervals over a 12-month period to evaluate its safety and efficacy. Device removal may be performed if adverse events occur or if deemed necessary by the investigator.