Tricuspid Annuloplasty for Moderate Tricuspid Regurgitation Associated With Miral Operation

Cardiac Surgery Clinical Trial

Official title: A Prospective Randomized Trial of Tricuspid Annuloplasty for Moderate Tricuspid Regurgitation Associated With Mitral Operation

Status Completed

Clinical Trial Summary

The mitral valve is the inflow valve into the main pumping chamber of the heart. It can become leaky or narrow, and cause blood to back up into the blood vessels of the lungs. When patients get symptoms from a leaky or narrow mitral valve, surgery is recommended to either fix or replace the valve. Many patients with mitral valve disease also develop a leaky tricuspid valve - the tricuspid valve is the inflow valve to the right side of the heart (the right heart pumps blood across the lungs). The amount of leakiness of the tricuspid valve is determined by an ultrasound test, and the amount of leakiness is graded as: none, mild, moderate, or severe. When a heart surgeon operates on a patient with a diseased mitral valve, he or she will fix the tricuspid valve if the tricuspid leakage is severe. This involves sewing a cloth-covered ring around the valve and narrowing it. If the tricuspid valve leakage is only mild (or absent), the surgeon will leave the tricuspid valve alone at the time of mitral valve surgery. If the tricuspid valve has moderate leakage surgeons are uncertain about what to do. In a recent review of thousands of patients across the nation having mitral valve surgery with moderately leaky tricuspid valves, 35 % of patients had tricuspid valve repair. Since the investigators don't know what the best approach is: to leave the moderately leaky tricuspid valve alone or to fix it with a cloth-covered ring, the investigators propose a study to determine which approach is best. Patients having mitral valve surgery with a moderately leaky tricuspid valve will be randomized to either 1. have a tricuspid valve repair or 2. to not have a tricuspid valve repair. The investigators will carefully follow these patients for two years and see if heart function is better among those who got their valve fixed.

Clinical Trial Description

Study Design:

This is a single-center prospective, randomized controlled clinical trial.

Enroll/Randomize: mitral operation alone, or mitral operation with tricuspid valve repair. Randomization will occur before operation.

Operation: The surgeon will perform mitral surgery and only those patients randomized to tricuspid valve repair will perform tricuspid valve repair using a rigid 3-dimensional annuloplasty ring using standard techniques. ;

Related Conditions & MeSH terms

• Cardiac Surgery
• Tricuspid Valve Insufficiency
• Tricuspid Valve Regurgitation

• NCT number: NCT01246947
• Study type: Interventional
• Source: University of Maryland, Baltimore
• Status: Completed
• Phase: N/A
• Start date: September 2010
• Completion date: February 2017