"TARGET 2.0 Study": Safety and Performance of the Cardiovalve TR Replacement System

"TARGET 2.0": Safety and Performance of the Cardiovalve Tricuspid valve replacement system in the treatment of subjects with tricuspid regurgitation- investigation: Cardiovalve Tricuspid Valve Replacement system (hereinafter referred to as Cardiovalve TR system) The system has not been granted CE mark at this time The Cardiovalve implant consists of three bovine pericardium tissue leaflets, self-expanding dual nitinol frame, and fabric. A total of 24 anchoring points affix the device to the native tricuspid annulus.

The Delivery System is intended to deliver the valve in the crimped position via the transfemoral venous approach. It comprises of a catheter assembly and handles. The handles knobs facilitate valve alignment and positioning in the native valve, and control the capsule expansion and release of the Cardiovalve implant.

The Cardiovalve TR Valve Replacement System is intended for reduction of tricuspid regurgitation (TR) in patients with symptomatic severe or greater secondary tricuspid regurgitation despite being treated with medical therapy for whom tricuspid valve replacement is deemed appropriate by a Heart Team. The system percutaneously delivers the Implant to the tricuspid valve via femoral vein access This investigation is a continuation for "TARGET" investigation and its purpose is to further demonstrate the efficiency and safety of the Cardiovalve system in the treatment of subjects with tricuspid regurgitation. The same subject population will be included, while applying the clinical and scientific knowledge accumulated in the TARGET investigation. This investigation will support the submission for obtaining marketing approval.