Early Feasibility Study of the Pivot Extend Device for Treating Severe Tricuspid Regurgitation in Adults Including High-Risk Patients

What this Trial Is About

This research aims to evaluate the safety and effectiveness of the investigational Pivot Extend device in adults aged 18 years or older who have severe and symptomatic tricuspid regurgitation TR and are suitable for a less invasive valve procedure. The study focuses on participants who face high risks with traditional heart valve surgery, such as elderly patients or those with other health issues. The device is being assessed to improve symptoms by helping the valve close more tightly. The Pivot Extend device is inserted through a small incision in the leg vein and guided to the heart using a catheter. It is designed to sit in the gap where the valve does not close properly, helping reduce blood leaking back through the valve. This study includes implantation of the device, followed by evaluations at various time points up to one year after the procedure to monitor device and procedural success as well as clinical outcomes. Participants will undergo screening including heart imaging and blood tests before device implantation. After the procedure, they will be monitored closely for safety and effectiveness at 30 days, 180 days, and 365 days. Researchers will assess the success of the device placement, improvements in symptoms, and overall heart function. The total duration of participation includes follow-up visits across one year to ensure thorough observation of outcomes and safety.

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