Comparing flexible band and rigid ring methods for treating tricuspid regurgitation

Flexible Band Versus Rigid Ring Annuloplasty for the Correction of Tricuspid

This study is testing which surgical method, a flexible band or a rigid ring, works better for fixing tricuspid regurgitation in patients who need heart surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Nanjing Medical University (Academic / other)
• Locations: 1 site (Nanjing)
• Trial ID: NCT04093297 on ClinicalTrials.gov

What this trial studies

This study aims to compare the effectiveness and long-term outcomes of two surgical techniques, flexible band annuloplasty and rigid ring annuloplasty, for correcting tricuspid regurgitation in patients with heart valve disease. It will involve patients aged 18 to 80 who have moderate or greater tricuspid regurgitation and require additional heart surgeries. The study will assess the outcomes through echocardiographic evaluations and patient follow-ups to determine which method provides better results.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with moderate to severe tricuspid regurgitation requiring concomitant heart surgery.

Not a fit: Patients with mild tricuspid regurgitation or those not requiring additional heart surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and quality of life for patients with tricuspid regurgitation.

How similar studies have performed: While there is limited data directly comparing these two methods, similar studies on heart valve interventions have shown promising results.

Eligibility criteria

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%.

Where this trial is running

Nanjing

• The First Affiliated Hospital of Nanjing Medical University — Nanjing, China (Recruiting)

Study contacts

• Study coordinator: Yong-feng Shao, MD

Conditions Tricuspid Regurgitation