Bradycardia; Sick Sinus Syndrome, AV Block Clinical Trial
Official title:
IntAct, Study on Promotion of Intrinsic Activity.
The purpose of this study is to provide evidence that the Refined Ventricular Pacing Algorithm leads to clinically relevant reduction (at least 50% reduction) of the incidence of ventricular pacing.
Electrical stimulation in the apex of the right ventricle ( ventricular pacing) usually
improves the heart function of patients with a pacemaker and can even be life-saving.
However, evidence is accumulating that ventricular pacing may also have undesired long-term
cardiac effects. Therefore, it makes sense to limit ventricular pacing to the absolute
required minimum. The functionality RVP (Refined Ventricular Pacing) in the C-series 2nd
generation pacemakers of Vitatron B.V. Arnhem, the Netherlands is designed to reduce
ventricular pacing.
After implantation of the Vitatron C50 D model C50A2 (pacemaker) or Vitatron C60 DR model
C60A2 (pacemaker) and a 4-6 weeks stabilization period, proper functioning of pacemaker and
leads (stimulation- and sensing parameters) is checked. The pacemakers will be programmed
according to predefined settings.
In the following 4-weeks Baseline period diagnostic data (atrial fibrillation burden and
percentage of ventricular pacing (% VP)) are collected in the pacemaker memory. Based on
these data, patients will be excluded from further participation (patients with more than
15% atrial fibrillation) or subdivided into three groups: (a) < 30% VP (30- VP group), (b)
>30% VP, Sick Sinus Syndrome and normal conductivity (SSS group), (c) >30% VP, 1st or 2nd
degree AV block. Patients in these three groups will be treated for 4 weeks alternatively
with the RVP functionality switched ON or OFF. The order will be determined by
randomization. At the end of these two cross-over periods the % VP and the judgment of the
patients of the last period will be assessed. Adverse events will be recorded from the
moment of study enrolment.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment