NCT00224341

Arrhythmia Restart Prevention and RatE STabilization in Atrial Fibrillation

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 360 (planned)
• Sponsor: Vitatron France · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this trial is to show the therapeutic efficacy of the preventive pacing therapies of the Selection 9000 and Vitatron T70 DR pacemakers, dedicated to handle atrial fibrillation (AF). Two new algorithms (post-AF response and ventricular rate stabilization \[VRS\]) will be assessed in a combined pathway, compared to a control group. The efficacy of the overall available therapies to prevent AF and its symptoms will then be assessed also.

Detailed description

Due to anti-arrhythmic pharmacological drugs failure to suppress atrial fibrillation (AF), interest towards preventive pacing treatments is increasing. The importance of this option in the panoply of the preventive tools is fully justified, only by considering the insufficiency, the complexity, or the poor reproducibility of the other non-pharmaceutical approaches. Preventive pacing therapies rely on their potential effect on different onset modalities emphasized by previous studies, and more generally by stabilizing atrial tissue when potential triggers are appearing. On top of that, cardiac stimulator can deliver these therapies when identifying these triggers but also can offer incomparable diagnostic tools, in terms of sensitivity, specificity and continuity in the monitoring. Four preventive pacing therapies have already been evaluated, the objective of this study is to show the clinical benefit brought by the new features of the Selection 9000 / Vitatron T70 DR.

Conditions

• Sick Sinus Syndrome
• Brady-Tachy Syndrome

Interventions

Type	Name	Description
DEVICE	Pacemaker Vitatron Selection 9000
DEVICE	Pacemaker Vitatron T70

Timeline

• Start date: 2003-11-01
• Completion: 2006-11-01
• First posted: 2005-09-22
• Last updated: 2006-10-18

Locations

37 sites across 1 country: France