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 ]
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 ]
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