NCT00156741

Efficacy of a Pacemaker Algorithm in Promotion of the Intrinsic Heart Activity.

IntAct, Study on Promotion of Intrinsic Activity.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (planned)
• Sponsor: Medtronic BRC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Bradycardia; Sick Sinus Syndrome, AV Block

Interventions

Type	Name	Description
DEVICE	Vitatron C50 D Model C50A2 of Vitatron C60 DR model C60A2
PROCEDURE	Required pacemaker setting

Timeline

• Start date: 2004-04-01
• Completion: 2006-04-01
• First posted: 2005-09-12
• Last updated: 2011-08-02

Locations

30 sites across 11 countries: Austria, Czechia, Denmark, Finland, Germany, Italy, Netherlands, Russia, Sweden, Switzerland, United Kingdom