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
  Purpose

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
Cardiomyopathy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: CRM and Fusion Beats: Effects of Progressive Fusion on Intra-left Ventricular Mechanical Function

Resource links provided by NLM:


Further study details as provided by Essentia Health:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 25
Study Start Date: January 2008
Study Completion Date: September 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observation
30 Patients with dualchamber pacemakers or implantable cardioverter-defibrillators (ICDs)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pacemaker clinic or inpatient EP at St. Marys' Medical Center Duluth MN

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610896

Locations
United States, Minnesota
Essentia Health
Duluth, Minnesota, United States, 55805
Sponsors and Collaborators
Essentia Health
Investigators
Principal Investigator: Michael E Mollerus, MD Essentia Health
  More Information

Publications:

Responsible Party: Michael E. Mollerus, MD, Essentia Health
ClinicalTrials.gov Identifier: NCT00610896     History of Changes
Other Study ID Numbers: 12-07-02
Study First Received: January 25, 2008
Last Updated: August 31, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cardiomyopathies
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 21, 2014