Mitral Insufficiency Reduction With Biventricular Pacing

NCT01242397 | Unknown Phase 1 DMC

• 1 other identifier: MiRBi- Acosta
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mitral Regurgitation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

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

  Chronic

Study Arms (2)

CRT ON

OTHER

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

Device: CRT pacing

CRT- OFF

OTHER

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

Device: CRT pacing

Interventions

CRT pacing 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 ON; CRT- OFF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• ≤ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Trinity Medical Center, Illinois: lead
• Medtronic: collaborator
• Duke University: collaborator
• Massachusetts General Hospital: collaborator
• Augusta University: collaborator

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• 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

  Augusta University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Helbert Acosta, MD

CONTACT

309-236-0810; mirbiacosta@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 10, 2010
• First Posted: November 17, 2010
• Study Start: January 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2013
• Last Updated: December 2, 2010

Record last verified: 2009-11