Mitral Regurgitation Clinical Trial
— MiRBiOfficial 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
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.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | January 2013 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patient is at least 18 years of age - Patients with moderate-to-severe or severe functional MR. - EROA > 40 mm2 and an MR/LA > 40% (severe) - 30 = EROA = 40 mm2 and 30 = MR/LA = 40% (moderate-to-severe) - Baseline rates of 50-90 beats per minute (patients with sinus rhythm) or AF - QRS < 120 ms - LVEF < 35% - Willing to sign informed consent - On standard stable heart failure medical regimen (beta blockers and ACE-I or ARBs) for at least 1 month before randomization, if tolerated - Patient has the ability to understand the requirements of the study, including consent for use and disclosure of research-related information - Patient has the ability to comply with study procedures and protocol, including required study visits Exclusion Criteria: - candidate for CRT or has a previously implanted CRT device - previously implanted implantable pulse generators (IPG) or implantable cardioverter defibrillator (ICD) with at least 10 % pacing in the right ventricle - patient has life expectancy <6 months - patient is pregnant - significant aortic stenosis - uncontrolled hypertension - mitral valve stenosis - severe mitral valve calcification - ruptured chordae tendinae or papillary muscle - mitral valve leaflet disorders (i.e. endocarditis, lupus, tumors, rheumatic heart disease) - chronic mitral leaflet degeneration (ie. Marfans) - previous valve replacement or surgery - IV inotropes or IV vasodilators - candidate for mitral valve repair or replacement surgery within the next 6 months - patient has in-hospital acute coronary syndrome (ACS) (NSTEMI/STEMI) prior to randomization - patient has planned or elective percutaneous coronary intervention (PCI) or other non-cardiac surgery prior to randomization - patient is currently enrolled in an investigational drug or device study - patient is clinically unstable per PI assessment |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Trinity Medical Center, Illinois | Duke University, Georgia Regents University, Massachusetts General Hospital, Medtronic |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Chronic(8 months post-implant) benefit of MR reduction | 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) | Chronic | Yes |
Secondary | To compare MR Severity (ERO and MR/LA area), heart volume and dimensions via echo and clinical symptoms between two pacing modalities | 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) | Chronic | No |
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