Sick Sinus Syndrome Clinical Trial
Official title:
Left Ventricular Function and Remodelling During Permanent Pacing
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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