NCT02675244

Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 401 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the research is to determine whether repairing a tricuspid valve (TV) in patients with mild to moderate tricuspid regurgitation (TR), at the time of planned mitral valve surgery (MVS), would improve the heart health of those who receive it compared to those who do not. At this point, the medical community is split in their opinion on whether surgeons should routinely repair mild to moderate TR in patients who are undergoing planned mitral valve surgery, and this study will answer this question.

Detailed description

The tricuspid valve controls the flow of blood in your heart between the right ventricle and the right atrium. TR is a condition where the valve does not close fully when it is supposed to and blood can then leak back into the right atrium. When TR becomes severe, surgery is usually performed to correct it. The purpose of the research is to determine whether repairing a tricuspid valve in patients with mild to moderate TR, at the time of planned mitral valve surgery, would improve the heart health of those who receive it compared to those who do not. There are no new or "experimental" procedures being tested in this study: both the mitral valve procedure and the tricuspid valve repair procedure are well established surgeries and are regularly performed together in patients who have severe TR. The available evidence addressing this issue is not definite: it is based on less rigorous methods of investigation, and the results have been conflicting. The study being proposed here will use rigorous scientific methods and should result in a very high level of certainty about what surgical treatment is best for patients with your condition. This study will enroll people scheduled for mitral valve surgery with mild to moderate tricuspid regurgitation.

Conditions

• Mild Tricuspid Regurgitation
• Moderate Tricuspid Regurgitation
• Tricuspid Regurgitation

Interventions

Type	Name	Description
PROCEDURE	TV Annuloplasty	TV Annuloplasty will be performed using standard surgical techniques
PROCEDURE	MVS	MVS will be performed using standard surgical techniques

Timeline

• Start date: 2016-05-26
• Primary completion: 2021-04-19
• Completion: 2021-04-19
• First posted: 2016-02-05
• Last updated: 2024-06-18
• Results posted: 2023-09-21

Locations

41 sites across 3 countries: United States, Canada, Germany