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

This study has been completed.
Sponsor:
Information provided by:
Essentia Health
ClinicalTrials.gov Identifier:
NCT00610896
First received: January 25, 2008
Last updated: August 31, 2011
Last verified: August 2011
History of Changes

January 25, 2008
August 31, 2011
January 2008
May 2010   (final data collection date for primary outcome measure)
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. [ Time Frame: unknown ] [ Designated as safety issue: No ]
Acute effect of mechanical dyssynchrony measured by septal to lateral wall delay using tissue doppler imaging between baseline non-fused AV conduction and varying degrees of paced and native AV conduction. [ Time Frame: unknown ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00610896 on ClinicalTrials.gov Archive Site
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. [ Time Frame: unknown ] [ Designated as safety issue: No ]
Stroke volume as measured by time velocity integral across the aorta valve between baseline non-fused AV conduction, and varying degrees of paced and native AV conduction. [ Time Frame: unknown ] [ Designated as safety issue: No ]
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CRM and Fusion Beats: Effects of Progressive Fusion on Intra-left Ventricular Mechanical Function
CRM and Fusion Beats: Effects of Progressive Fusion on Intra-left Ventricular Mechanical Function

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".
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Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Pacemaker clinic or inpatient EP at St. Marys' Medical Center Duluth MN
Cardiomyopathy
Not Provided
Observation
30 Patients with dualchamber pacemakers or implantable cardioverter-defibrillators (ICDs)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
September 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00610896
12-07-02
No
Michael E. Mollerus, MD, Essentia Health
Essentia Health
Not Provided
Principal Investigator: Michael E Mollerus, MD Essentia Health
Essentia Health
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP