NCT07172477

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

Early Feasibility Study (EFS) of the 'Pivot Extend' for the Treatment of Tricuspid Regurgitation, Including High-Risk Patients (SPACER Study, Australia)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Tau Medical Australia Pty Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Tricuspid Regurgitation

Interventions

Type	Name	Description
DEVICE	Pivot Extend	The investigational "Pivot Extend" device will be inserted through a small incision in the femoral vein and guided to the heart using a catheter. The Pivot Extend device is designed to sit in the space where the valve isn't closing, helping the flaps of the valve to close tightly and reducing the amount of blood leaking back through the valve.

Timeline

• Start date: 2025-11-11
• Primary completion: 2026-04-01
• Completion: 2027-03-01
• First posted: 2025-09-15
• Last updated: 2025-12-09

Locations

1 site across 1 country: Australia