Flexible Band Versus Rigid Ring Annuloplasty for the Correction of Tricuspid
Tricuspid regurgitation is common in patients with heart valve disease, both flexible band and rigid ring annuloplasty can correct this anomaly. However, there is no data to address which one can bring more benefits to these patients with combined heart valve disease. This study aims to prospectively compare the efficacy and long term outcomes of flexible band versus rigid ring annuloplasty for the correction of tricuspid regurgitation.
• 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;