Band Versus Ring for Tricuspid Regurgitation

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Sep 16, 2019

Keywords

ClinConnect Summary

This clinical trial is comparing two different surgical methods for treating tricuspid regurgitation, a condition where the heart valve does not close properly, allowing blood to flow backward. The trial will look at the effectiveness and long-term results of using a flexible band versus a rigid ring to fix this problem. Both methods are commonly used in patients who also have other heart valve issues, but this study aims to find out which one works better.

To be eligible for the trial, participants need to be between 18 and 80 years old and have moderate to severe tricuspid regurgitation, as shown by heart ultrasound tests. They must also be planning to have other heart surgeries at the same time. Participants will receive information about the trial and must agree in writing before joining. If you choose to participate, you’ll be monitored after the procedure to check on your recovery. This study is currently looking for volunteers, and it's important to know that certain health conditions and previous surgeries might exclude someone from taking part.

Gender

ALL

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%.