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Mitral Insufficiency Reduction With Biventricular Pacing (MiRBi)

Primary Purpose

Mitral Regurgitation

Status

Unknown status

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

CRT pacing

About this trial

This is an interventional treatment trial for Mitral Regurgitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

CRT ON

CRT- OFF

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

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

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)

Full Information

NCT ID

NCT01242397

First Posted

November 10, 2010

Last Updated

December 1, 2010

Sponsor

Trinity Medical Center, Illinois

Collaborators

Medtronic, Duke University, Massachusetts General Hospital, Augusta University

1. Study Identification

Unique Protocol Identification Number

NCT01242397

Brief Title

Mitral Insufficiency Reduction With Biventricular Pacing

Acronym

MiRBi

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2009

Overall Recruitment Status

Unknown status

Study Start Date

January 2011 (undefined)

Primary Completion Date

January 2012 (Anticipated)

Study Completion Date

January 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Trinity Medical Center, Illinois

Collaborators

Medtronic, Duke University, Massachusetts General Hospital, Augusta University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mitral Regurgitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CRT ON

Arm Type

Other

Arm Description

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

Arm Title

CRT- OFF

Arm Type

Other

Arm Description

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

Intervention Type

Device

Intervention Name(s)

CRT pacing

Intervention Description

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.

Primary Outcome Measure Information:

Title

Chronic(8 months post-implant) benefit of MR reduction

Description

Time Frame

Chronic

Secondary Outcome Measure Information:

Title

To compare MR Severity (ERO and MR/LA area), heart volume and dimensions via echo and clinical symptoms between two pacing modalities

Description

Time Frame

Chronic

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Helbert Acosta, MD

Phone

309-236-0810

mirbiacosta@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Helbert Acosta, MD

Organizational Affiliation

Trinity Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Patrick Hranitzky, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jagmeet Singh, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Adam A Berman, MD

Organizational Affiliation

Augusta University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Mitral Insufficiency Reduction With Biventricular Pacing

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