Early Feasibility Study of the Trisol System
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).
• Age \>18 years.
• Subject meets the legal minimum age to provide informed consent based on local regulatory requirements.
• 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).
• New York Heart Association (NYHA) Functional Class II to IVa.
• Participant is deemed at high surgical risk or greater for tricuspid valve surgery and appropriate for transcatheter tricuspid valve replacement as determined by the local Heart Team.
• Participant adequately treated based upon medical standards, including for coronary artery disease, mitral regurgitation, and Guideline-Directed Medical Therapy (GDMT) for heart failure for at least 30-days prior to index procedure.
• Male or non-pregnant female.
• Participant understands the nature of the procedure and provides written informed consent prior to any study specific assessments.
• Participant is willing and able to comply with the specified study requirements and follow-up evaluations.
⁃ Participant is anatomically suitable for the Trisol system, including trans-jugular access as per imaging requirements, and is approved by the Subject Screening Committee