Mitral Insufficiency Reduction With Biventricular Pacing — MiRBi  

Mitral Regurgitation Clinical Trial

Official title: Prospective.Randomized, Blinded, Crossover Chronic IDE Study of the Effects of Pacing on Mitral Regurgitation in Patients Without Standard Indications for Cardiac Resynchronization Therapy

Status Not yet recruiting

Clinical Trial Summary

The purpose of this study is to show that CRT(Cardiac Resynchronization Therapy) pacing in patients with severe functional MR (Mitral Regurgitation) who are not currently indicated for CRT will demonstrate chronic benefit of MR reduction( via echo measured MR/LA area and ERO per American Society of ECHO guidelines) and to show that CRT pacing is safe in these patients.

Clinical Trial Description

Approximately 50 patients will be randomized, followed and analyzed in this prospective study. Patients who meet all inclusion and no exclusion criteria will be enrolled and implanted with a CRT system. Baseline evaluation, which includes clinical symptom evaluation and an echocardiogram, will be performed at the time of randomization, which should occur as soon after device implant as possible but no later than 2 week post -implant. The baseline echocardiogram should be acquired prior to the device being programmed to the randomized setting. Repeat echocardiograms and scheduled follow-up evaluations will be performed at the end of each 3 month crossover period. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

• NCT number: NCT01242397
• Study type: Interventional
• Source: Trinity Medical Center, Illinois
• Contact: Helbert Acosta, MD
• Phone: 309-236-0810
• Email: mirbiacosta@gmail.com
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: January 2011
• Completion date: January 2013