The objective of this first in human study is to gain early clinical insight into the safety profile and performance of the Topaz transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.

The TRiCares Topaz Prosthesis is intended to replace a diseased tricuspid heart valve via a transcatheter approach without removing the native valve.

Inclusion Criteria:

• Subject of age >18 years.

• Subject with severe symptomatic tricuspid regurgitation presenting following conditions:

  1. TR severity of at least 3 (severe) on a scale of 0 (none) to 5 (torrential), assessed by independent core lab and/or
  2. symptoms requiring use of diuretics.

• Subject presenting with New York Heart Association Class NYHA ≥II.

• Subject is not eligible for open tricuspid valve surgery due to high operative risk, as determined by a Heart Team decision.

Exclusion Criteria:

• Subject in need of emergent or urgent intervention or any planned cardiac intervention within the next 12 months.
• Subject undergoing cardiac interventions within 30 days prior to index procedure.
• Subject with concomitant clinically relevant mitral, aortic, pulmonary regurgitation/stenosis.
• Subject who had previous tricuspid valve replacement or repair and a device is still in situ.