Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation

Summary

The purpose of this clinical study is to evaluate the safety and clinical efficacy of the VDyne System in the treatment of symptomatic severe tricuspid regurgitation (TR).

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Device
  VDyne Transcatheter Tricuspid Valve Replacement System

  The study investigational device is the VDyne Transcatheter Tricuspid Valve Replacement System which consists of a bioprosthetic implantable tricuspid valve, the VDyne Delivery System, Drop Tether, accessories that facilitate the placement of the valve and the VDyne Retrieval System. The VDyne Valve is deployed by transfemoral implantation within the native tricuspid valve and is implanted under fluoroscopic and transesophageal echocardiography (TEE) guidance, while the heart remains beating, without the use of CPB. The valve is repositionable and fully retrievable intraoperatively. Repositioning allows optimization of the valve position following deployment, and retrieval, with the VDyne Retrieval System, allows use of an alternative valve size or removal of the index VDyne Valve in the event of suboptimal valve delivery or other intraoperative complication.

Locations (11)