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Left Ventricular Function and Remodelling During Permanent Pacing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00228241
Recruitment Status : Unknown
Verified September 2005 by Aarhus University Hospital Skejby.
Recruitment status was:  Active, not recruiting
First Posted : September 28, 2005
Last Update Posted : October 26, 2006
Information provided by:
Aarhus University Hospital Skejby

Brief Summary:
  1. Background - Pacemaker treatment gives asynchronous activation of the heart that often results in decreased heart function and clinical heart failure. New pacemaker types that stimulates both left and right ventricle ( biventricular pacemakers ) is introduced to the treatment of patients with heart failure, decreased left ventricular function and ECG signs with left bundle branch block.
  2. Hypothesis - Ventricular pacing results in remodelling of the left ventricle and decreased left ventricular function. Biventricular pacing do not do this. Ventricular pacing results in heart failure and increased wall stress with decreased 6 minutes walk test and increased BNP in blood samples. This is not seen by biventricular pacing.
  3. Materials and methods - 3 studies. All patients are examined by echocardiography 2-dimensional, M-mode, 3-dimensional and with tissue harmonic imaging. Study 1) Patients with AV-conduction disorder that needs pacemaker treatment are randomized to DDD-pacemaker or biventricular pacemaker. Study 2) Patients with sick sinus syndrome included in DANPACE are randomized to AAI- or DDD-pacemaker. Study 3 ) Acute study to examine the changes in patients AV-block before DDD-pacemaker implantation and after implantation.

Condition or disease Intervention/treatment Phase
Sick Sinus Syndrome AV-Block Device: AAI vs. DDD vs. BIV pacing in different patients groups Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Left Ventricular Function and Remodelling During Permanent Pacing
Study Start Date : September 2003
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 3-dimensional left ventricular ejection fraction

Secondary Outcome Measures :
  1. TDI echo parameters
  2. 6 MHW
  3. NT-proBNP

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Sick sinus syndrome
  • AV-block

Exclusion Criteria:

  • Atrial fibrillation
  • AMI
  • Heart valve disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00228241

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Andi Eie Albertsen
Aarhus, Denmark, 8200
Sponsors and Collaborators
Aarhus University Hospital Skejby
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Study Chair: Andi Albertsen, MD Physician, Skejby University Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00228241     History of Changes
Other Study ID Numbers: 130472
First Posted: September 28, 2005    Key Record Dates
Last Update Posted: October 26, 2006
Last Verified: September 2005
Keywords provided by Aarhus University Hospital Skejby:
Sick sinus syndrome
Additional relevant MeSH terms:
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Sick Sinus Syndrome
Atrioventricular Block
Pathologic Processes
Arrhythmia, Sinus
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Heart Block
Cardiac Conduction System Disease