Sick Sinus Syndrome Clinical Trial
Official title:
The Danish Multicenter Randomised Study on AAI Versus DDD Pacing in Sick Sinus Syndrome
Hypothesis Treatment with rate adaptive single chamber atrial pacing (AAIR) reduces the risk
of death compared with rate adaptive dual chamber pacing (DDDR) in patients with sick sinus
syndrome (SSS).
Primary purpose The primary purpose of this randomised trial is to compare AAIR and DDDR
pacing in patients with SSS and normal atrioventricular (AV) conduction with respect to the
primary end point overall mortality.
Background In patients with isolated SSS, who need pacemaker treatment, any pacemaker can be
used to treat the symptomatic bradycardia: a single chamber atrial (AAI) pacemaker, a single
chamber ventricular (VVI) pacemaker, or a dual chamber (DDD) pacemaker. In the USA and in
most European countries, DDD pacing is used in most cases. It is now known from the Danish
AAI/VVI trial, that AAI pacing is superior to VVI pacing, since VVI pacing is associated
with a higher mortality and a higher incidence of atrial fibrillation, thromboembolic
complications and heart failure. This confirms previous findings in observational studies.
Therefore, VVI pacing should no longer be used in patients with SSS.
The main argument for using DDD pacing is the concern, that the patients will develop
symptomatic atrioventricular (AV) block. In the Danish AAI/VVI trial, the risk of AV block
was approximately 0.6% per year, which is equivalent to the risk found in a larger meta
analysis. This is only a little higher that the risk of atrioventricular block in the
age-matched non-paced population. Implantation of a DDD pacemaker in all patients will
effectively prevent development of symptomatic bradycardia in the minority of patients who
develops AV block. However, the most important disadvantage during DDD pacing is the
stimulation (pacing) of the ventricles by the pacemaker a large part of the time, also in
patients without AV block. Pacing the right ventricle causes an asynchronous electrical
activation and mechanical contraction of the ventricles as compared with the normal
physiological contraction.
At present time, a randomised comparison of AAI and DDD pacing in patients with SSS has
never been conducted, and to our knowledge, such a trial is not planned anywhere else.
Since several of the patients with SSS suffer from chronotropic incompetence, pacemakers
with rate adaptive function are chosen for all patients included in the present trial.
All patients, that fulfils the inclusion criteria and none of the exclusion criteria and who
give written informed consent, are included into the study. For all other patients
undergoing primary pacemaker implantation in the study period, an exclusion data sheet is
filled in stating the reason for exclusion. A total of 1,900 patients are included into the
study.
Prior to the pacemaker implantation patients are randomised by lot (envelope) to either AAIR
or DDDR pacing. The randomisation is performed after written informed consent has been
obtained from the patient. Randomisation will ensure that all centres will randomise an
equal number of patients into each treatment group.
Patients randomised to AAIR pacing will have a bipolar lead implanted in their right atrium
connected to a single chamber pacemaker with rate adaptive function. Patients randomised to
DDDR pacing will have two leads (one bipolar lead in their right atrium and a uni- or
bipolar lead in their right ventricle) connected to a DDDR pacemaker.
Out of hospital follow-up The patients must attend for out of hospital follow-up after 3
months and 12 months and then once every year.
Criteria for closing the study
The DANPACE study is stopped and results are analysed when all of the following three
criteria are fulfilled:
1. 1,900 patients have been randomised.
2. The last randomised patient has been followed for at least 1 year.
3. The mean follow-up for the whole study population is at least 5.5 years.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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