Efficacy of a Pacemaker Algorithm in Promotion of the Intrinsic Heart Activity.
Bradycardia; Sick Sinus Syndrome, AV Block
Device: Vitatron C50 D Model C50A2 of Vitatron C60 DR model C60A2
Procedure: Required pacemaker setting
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||IntAct, Study on Promotion of Intrinsic Activity.|
- Calculation of reduction in % VP when RVP algorithm is ON versus OFF, recording % VP at 4 and 8 weeks after randomization
- Occurrence of possible undesired consequences of the RVP algorithm (e.g. retrograde conduction; AF burden) and adverse events in the periods with the algorithm switched ON versus OFF, 4 and 8 weeks after randomization
- Patient's opinion about treatment (on a six-point scale), at 4 and 8 weeks after randomization
- explorative subanalysis on patients with different arrhythmias and/or conducting system defects to investigate in which type of patients the RVP algorithm will have the largest impact on %VP
- Reproducibility of the %VP assessment, comparison %VP during Baseline periode and 4-week study period with RVP OFF
|Study Start Date:||April 2004|
|Estimated Study Completion Date:||April 2006|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00156741
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|Study Chair:||Ludwig Binner, MD||Universitätsklinikum Ulm, Ulm, Germany|
|Study Director:||Chris van Groeningen, MD||Vitatron B.V., Arnhem, The Netherlands|