Clinical Trial: Arrhythmia Restart Prevention and RatE STabilization in Atrial Fibrillation

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title:

Brief 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 Summary:

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.


Sponsor: Vitatron France

Current Primary Outcome:

  • Show clinical benefit of post-AF response and VRS algorithms, when combined versus compared with a control group: In a conventional dual chamber (DDD) configuration
  • In a configuration including all the preventive pacing therapies of the device
  • The primary endpoint is the atrial fibrillation burden.


Original Primary Outcome:

  • Show clinical benefit of Post-AF Response and VRS algorithms, when combined, compared with a control group:
  • - In a conventional DDD configuration,
  • - In a configuration including all the preventive pacing therapies of the device.
  • The primary endpoint is the atrial fibrillation burden.


Current Secondary Outcome:

  • Assess the effect of post-AF response and VRS, when combined versus compared with a control group, in a conventional DDD configuration and another configuration which includes all PPT, on: Number (Nb) of hospitalizations
  • Nb of cardioversions
  • Symptom score
  • Restarts
  • Daily incidence of AF
  • Mean sinus rhythm duration
  • Assess clinical benefit of the overall AF therapies, as compared with the first four algorithms of the previous device (one continuous overdrive +3 triggered overdrive), on the same outcomes as above and AF burden


Original Secondary Outcome:

  • 1- Assess the effect of Post-AF Response and VRS, when combined versus control group, in a conventional DDD configuration and another configuration which includes all PPT, on :
  • - Nb of hospitalizations,
  • - Nb of cardioversions,
  • - Symptoms score,
  • - Restarts,
  • - Daily incidence of AF,
  • - Mean sinus rhythm duration
  • 2- Assess clinical benefit of the overall AF therapies, as compared with the first four algorithms of the previous device (one continuous overdrive + 3 triggered overdrive), on the same outcome as above + AF burden.


Information By: Vitatron France

Dates:
Date Received: September 20, 2005
Date Started: November 2003
Date Completion: November 2006
Last Updated: October 17, 2006
Last Verified: September 2005