IRB Study Number 24-305
Status Recruiting
Institute Heart and Vascular Institute
Description
The Trisol System is intended for use in adult patients with moderate to torrential tricuspid regurgitation (TR) who require replacement of their native tricuspid heart valve and are at high risk for surgical tricuspid valve intervention, as determined by a heart team, including a cardiac surgeon. The Trisol Delivery System allows the interventionalist to position and implant the valve in the appropriate anatomic location in the tricuspid valve annulus.
Inclusion Criteria
- 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).
Exclusion Criteria
- Previous tricuspid valve repair or replacement which may impede proper study device delivery or deployment.
- Stroke or transient ischemic event within the previous 90 days.
- Acute myocardial infarction within the previous 90 days.
