Study Comparing Combined Mitral and Tricuspid Valve Repair Versus Mitral Repair Alone for Mild to Moderate Tricuspid Regurgitation in Mitral Valve Surgery Patients

What this Trial Is About

Researchers are evaluating the effectiveness of surgical treatment for less severe functional tricuspid regurgitation TR in patients undergoing mitral valve surgery. The study focuses on patients with mild to moderate TR grade 2 or less and a dilated tricuspid annulus, where current guidelines recommend surgery but lack strong scientific evidence. This multicenter, randomized trial aims to clarify whether adding tricuspid annuloplasty to mitral valve repair improves outcomes, especially in patients with degenerative disease causes. Participants will be randomly assigned to one of two groups one receiving mitral valve repair alone Mitral-Only Group and the other receiving both mitral valve repair and tricuspid annuloplasty using an Edwards MC3 Tricuspid ring M & T Repair Group. The surgical procedures occur during the same operation, with patients blinded to their group assignment. Each group will include 71 patients. During the study, researchers will monitor patients for recurrence or worsening of tricuspid regurgitation by at least two grades using transthoracic echocardiography at discharge and 12 months after surgery. They will also assess long-term outcomes at 5 and 10 years. Safety, freedom from reoperation, and progression of TR will be evaluated using statistical methods. Participants will be followed for up to 10 years after surgery.

Annuloplasty for Not-Severe TR in Patients Undergoing MV Repair Versus Mitral Repair Only (NOSTRUM)