Mitral Insufficiency Reduction With Biventricular Pacing

NCT ID: NCT01242397

Last Updated: 2010-12-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-01-31

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 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.

Conditions

Mitral Regurgitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CRT ON

After implant, patients will be randomized to CRT pacing ON vs OFF in crossover fashion with 3 months in each period

Group Type: OTHER

CRT pacing

Intervention Type: DEVICE

The chronic effect of CRT pacing on the degree of MR in pts with severe-to-moderate or severe functional MR. The treatment being studied is CRT pacing therapy with standard of care LV lead placement. Patients will be randomized to CRT pacing ON vs. OFF and followed for a total of up to 8 months. This includes two 3-month crossover periods for each pacing modality (CRT ON and CRT OFF) and a 6-week washout period between these periods.

CRT- OFF

After implant, patients will be randomized to CRT pacing OFF vs ON in crossover fashion with 3 months in each period

Group Type: OTHER

CRT pacing

Intervention Type: DEVICE

The chronic effect of CRT pacing on the degree of MR in pts with severe-to-moderate or severe functional MR. The treatment being studied is CRT pacing therapy with standard of care LV lead placement. Patients will be randomized to CRT pacing ON vs. OFF and followed for a total of up to 8 months. This includes two 3-month crossover periods for each pacing modality (CRT ON and CRT OFF) and a 6-week washout period between these periods.

Interventions

CRT pacing

The chronic effect of CRT pacing on the degree of MR in pts with severe-to-moderate or severe functional MR. The treatment being studied is CRT pacing therapy with standard of care LV lead placement. Patients will be randomized to CRT pacing ON vs. OFF and followed for a total of up to 8 months. This includes two 3-month crossover periods for each pacing modality (CRT ON and CRT OFF) and a 6-week washout period between these periods.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Augusta University

OTHER

Sponsor Role: collaborator

Trinity Medical Center, Illinois

OTHER

Sponsor Role: lead

Responsible Party

Trinity Medical Center

Principal Investigators

Helbert Acosta, MD

Role: PRINCIPAL_INVESTIGATOR

Trinity Medical Center

Patrick Hranitzky, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Jagmeet Singh, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Adam A Berman, MD

Role: PRINCIPAL_INVESTIGATOR

Augusta University

Central Contacts

Helbert Acosta, MD

Role: CONTACT

Phone: 309-236-0810

Email: mirbiacosta@gmail.com

Other Identifiers

MiRBi- Acosta

Identifier Type: -

Identifier Source: org_study_id