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Mitral Insufficiency Reduction With Biventricular Pacing

NCT01242397 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2010-12-02

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Duke University

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • Augusta University

    collaborator OTHER

  • Trinity Medical Center, Illinois

    lead OTHER

Principal Investigators

  • Helbert Acosta, MD · Trinity Medical Center

  • Patrick Hranitzky, MD · Duke University

  • Jagmeet Singh, MD · Massachusetts General Hospital

  • Adam A Berman, MD · Augusta University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-01-31
Completion
2013-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01242397 on ClinicalTrials.gov