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Mitral Insufficiency Reduction With Biventricular Pacing (MiRBi)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Trinity Medical Center, Illinois.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Medtronic
Duke University
Massachusetts General Hospital
Georgia Regents University
Information provided by:
Trinity Medical Center, Illinois
ClinicalTrials.gov Identifier:
NCT01242397
First received: November 10, 2010
Last updated: December 1, 2010
Last verified: November 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Mitral Regurgitation
 Device: CRT pacing
 Phase 1

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

Further study details as provided by Trinity Medical Center, Illinois:

Primary Outcome Measures:
  • Chronic(8 months post-implant) benefit of MR reduction [ Time Frame: Chronic ] [ Designated as safety issue: Yes ]
    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)


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 50
Study Start Date: January 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
CRT ON
After implant, patients will be randomized to CRT pacing ON vs OFF in crossover fashion with 3 months in each period
 Device: 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.
CRT- OFF
After implant, patients will be randomized to CRT pacing OFF vs ON in crossover fashion with 3 months in each period
 Device: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01242397

Contacts
Contact: Helbert Acosta, MD 309-236-0810 mirbiacosta@gmail.com

Sponsors and Collaborators
Trinity Medical Center, Illinois
Medtronic
Duke University
Massachusetts General Hospital
Georgia Regents University
Investigators
Principal Investigator: Helbert Acosta, MD Trinity Medical Center
Principal Investigator: Patrick Hranitzky, MD Duke University
Principal Investigator: Jagmeet Singh, MD Massachusetts General Hospital
Principal Investigator: Adam A Berman, MD Georgia Regents University
  More Information

No publications provided

Responsible Party: Helbert Acosta MD, Trinity Medical Center
ClinicalTrials.gov Identifier: NCT01242397     History of Changes
Other Study ID Numbers: MiRBi- Acosta
Study First Received: November 10, 2010
Last Updated: December 1, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013