Band Versus Ring for Tricuspid Regurgitation

This is an interventional treatment trial for Tricuspid Regurgitation Read More

Inclusion Criteria:

• 1. Subject must be 18 years and 80 years at time of consent and must not be a member of a vulnerable population.
• 2. Subject or a legally authorized representative (where allowed per local regulations) must provide written informed consent prior to any trial related procedure.
• 3. Subjects with moderate or greater tricuspid regurgitation determined by the assessment of a qualifying transthoracic echocardiogram (TTE) and/or transesophageal echocardiogram (TEE).
• 4. Subjects with moderate tricuspid regurgitation will only be included in the trial if moderate tricuspid regurgitation is accompanied by a tricuspid annular diameter of ≥ 40mm as measured by echocardiography.
• 5. Isolated functional symptomatic tricuspid regurgitation of moderate to severe or greater, with annular dilatation of ≥ 40mm;
• 6. Requirement for concomitant left heart valve surgery;
• 7. Requirement for concomitant coronary artery surgery;
• 8. Requirement for concomitant atrial fibrillation surgery;
• 9. Available and able to return to the study site for post-procedural follow-up examination;

Exclusion Criteria:

• 1. Patient unable or unwilling to provide informed consent;
• 2. Subjects with mild tricuspid regurgitation;
• 3. Emergency surgery;
• 4. Prior tricuspid valve leaflet surgery or any currently implanted prosthetic tricuspid valve, or any prior transcatheter tricuspid valve procedure;
• 5. Subjects with percutaneous coronary intervention within prior 30 days prior to enrollment;
• 6. Subjects with presence of any known life threatening (non-cardiac major or progressive disease), non-cardiac disease that will limit the subject's life expectancy to less than one year;
• 7. Subjects with permanent or temporary pacemaker implantation;
• 8. Subjects with severe, irreversible pulmonary hypertension in the judgment of the investigator;
• 9. History of mitral/tricuspid endocarditis within the last 12 months;
• 10. Subjects with contraindication or known allergy to device's components, aspirin, anti-coagulation therapy or contrast media that cannot be adequately premeditated;
• 11. Subjects with bleeding or coagulation disorders (e.g. active peptic ulcer or active gastrointestinal bleeding);
• 12. Female patient is pregnant (urine HCG test result positive) or lactating;
• 13. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint;
• 14. Subjects with left ventricular ejection fraction (LVEF)≤20%.