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CRM and Fusion Beats: Effects of Progressive Fusion on Intra-left Ventricular Mechanical Function

Sponsor
Essentia Health (Other)
Overall Status
Completed
CT.gov ID
NCT00610896
Collaborator
(none)
25
Enrollment
1
Location
32
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is looking at cardiac rhythm management (CRM) and fusion beats in patients who have a pacemaker or implantable cardioverter-defibrillator (ICD), to determine if there is a correlation between the time between the contraction of the upper chambers of the heart (atrium) and the lower chambers of the heart, (ventricle) and heart function.

Some studies of people with pacemakers have been done to determine if shortening the time of contraction between the atrium and ventricle could benefit the function of the left ventricle. These studies have shown that there is no benefit in heart function.There have been other studies which have shown that chronic pacing of the right ventricle, especially with the lead placed at the tip of the right ventricle, can lead to a decrease in the function of the left ventricle and congestive heart failure. In some patients long term pacing of the right ventricle has also been associated with a reduction in the ability of the left ventricle to pump blood. This is know as a reduced left ventricular ejection fraction, which can be documented by an echocardiogram.

This study proposes to evaluate the acute effects of progressive paced fusion beats on the left ventricle to answer the question whether there is an delay between the atrium and ventricle that is "too long" or "too short".

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    25 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    CRM and Fusion Beats: Effects of Progressive Fusion on Intra-left Ventricular Mechanical Function
    Study Start Date :
    Jan 1, 2008
    Actual Primary Completion Date :
    May 1, 2010
    Actual Study Completion Date :
    Sep 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    Observation

    30 Patients with dualchamber pacemakers or implantable cardioverter-defibrillators (ICDs)

    Outcome Measures

    Primary Outcome Measures

    1. Acute effect of mechanical dyssynchrony measured by septal to lateral wall delay using tissue doppler imaging between baseline non-fused atrioventricular conduction and varying degrees of paced and native atrioventricular conduction. []

    Secondary Outcome Measures

    1. Stroke volume as measured by time velocity integral across the aorta valve between baseline non-fused atrioventricular conduction, and varying degrees of paced and native atrioventricular conduction. []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Dual chamber pacemaker or ICD device

    • Left Ventrical Ejection Fraction (LVEF) 40% or less

    • Sinus Rhythm with intact atrioventricular conduction with a PR interval greater than 200 msec QRS less than 120 msec

    • Pacing right ventricle lead in the right ventricular apex (RVA), system implanted within 6 weeks or chronically implanted system with histograms showing 20% or less right ventricle pacing

    Exclusion Criteria:

    • LVEF greater than 40%,

    • Any rhythm other than sinus rhythm

    • Second degree or higher atrioventricular block

    • Native Heart Rate less than 40 beats per minute or greater than 90 beats per minute

    • Left ventricle or Chronic Sinus lead in non-RVA location

    • Chronically implanted system with greater than 20% right ventricle pacing

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Essentia Health Duluth Minnesota United States 55805

    Sponsors and Collaborators

    • Essentia Health

    Investigators

    • Principal Investigator: Michael E Mollerus, MD, Essentia Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00610896
    Other Study ID Numbers:
    • 12-07-02
    First Posted:
    Feb 8, 2008
    Last Update Posted:
    Sep 2, 2011
    Last Verified:
    Aug 1, 2011
    Additional relevant MeSH terms:
    Cardiomyopathies

    Study Results

    No Results Posted as of Sep 2, 2011