Trisol Medical
The objective of this early feasibility study is to gain early clinical insight into Trisol system safety and performance to treat patients with moderate or greater tricuspid regurgitation (TR).
A prospective, single-arm, open-label, multi-center early feasibility clinical study.
Inclusion Criteria: 1. Age \>18 years. 2. Subject meets the legal minimum age to provide informed consent based on local regulatory requirements. 3. Participant has symptomatic, moderate or greater functional or degenerative tricuspid regurgitation (TR) as determined by the Echocardiography Core Lab assessment of a qualifying transthoracic echocardiogram (TTE) and/or transesophageal echocardiogram (TEE). 4. New York Heart Association (NYHA) Functional Class II to IVa. 5. Participant is deemed at high surgical risk or greater for tricuspid valve surgery and appropriate for transcatheter tricus…
Replacement of the tricusupid valve using Trisol System in a transcatheter approach