Band Versus Ring for Tricuspid Regurgitation

Study Overview
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Brief Summary
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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.

Official Title
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Flexible Band Versus Rigid Ring Annuloplasty for the Correction of Tricuspid

Conditions
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Tricuspid Regurgitation

Intervention / Treatment
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* Procedure: Tricuspid Annuloplasty


Participation Criteria
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Eligibility Criteria
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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%.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group Ring<br>Patients in Group Ring will undergo tricuspid rigid ring annuloplasty | Procedure: Tricuspid Annuloplasty<br>* Patients will undergo repair of tricuspid regurgitation<br>|
| Active Comparator: Group Band<br>Patients in Group Band will undergo flexible band annuloplasty | Procedure: Tricuspid Annuloplasty<br>* Patients will undergo repair of tricuspid regurgitation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in severity of tricuspid regurgitation | Improvement in tricuspid regurgitation: refers to Mild or No tricuspid regurgitation Tricuspid regurgitation is graded as mild, moderate, and severe based on regurgitant jet area | within 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Mortality: Mortality within hospital stay or 1 month postoperative. | up to 3 months of intervention |