Left Ventricular Function and Remodelling During Permanent Pacing
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
3-dimensional left ventricular ejection fraction
TDI echo parameters
Male or female participants at least 20 years old.
Inclusion Criteria: - Sick sinus syndrome - AV-block Exclusion Criteria: - Atrial fibrillation - AMI - Heart valve disease
|Official title||Left Ventricular Function and Remodelling During Permanent Pacing|
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