This trial is active, not recruiting.

Conditions sick sinus syndrome, av-block
Treatment aai vs. ddd vs. biv pacing in different patients groups
Sponsor Aarhus University Hospital Skejby
Start date September 2003
End date July 2006
Trial size 100 participants
Trial identifier NCT00228241, 130472


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

3-dimensional left ventricular ejection fraction
time frame:

Secondary Outcomes

TDI echo parameters
time frame:
time frame:
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Eligibility Criteria

Male or female participants at least 20 years old.

Inclusion Criteria: - Sick sinus syndrome - AV-block Exclusion Criteria: - Atrial fibrillation - AMI - Heart valve disease

Additional Information

Official title Left Ventricular Function and Remodelling During Permanent Pacing
Trial information was received from ClinicalTrials.gov and was last updated in October 2006.
Information provided to ClinicalTrials.gov by Aarhus University Hospital Skejby.