Clinical Trial: Mitral Insufficiency Reduction With Biventricular Pacing

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

Brief 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.

Detailed Summary: 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.
Sponsor: Trinity Medical Center, Illinois

Current Primary Outcome: Chronic(8 months post-implant) benefit of MR reduction [ Time Frame: Chronic ]

To show that CRT pacing in patients with severe functional MR who are not currently indicated for CRT will demonstrate chronic(8 months post-implant) benefit of MR reduction (via echo measured MR/LA area and ERO per American Society of Echo guidelines)


Original Primary Outcome: Same as current

Current Secondary Outcome: To compare MR Severity (ERO and MR/LA area), heart volume and dimensions via echo and clinical symptoms between two pacing modalities [ Time Frame: Chronic ]

Secondary objectives will compare MR severity (ERO and MR/LA area), heart volume and dimensions via echo (LA and LV), LVEF via echo (Simpson's method and clinical sypmtoms (NYHA class, QOL, 6MHW distance) between the two pacing modalities (CRT ON and OFF)


Original Secondary Outcome: Same as current

Information By: Trinity Medical Center, Illinois

Dates:
Date Received: November 10, 2010
Date Started: January 2011
Date Completion: January 2013
Last Updated: December 1, 2010
Last Verified: November 2009