Arrhythmia Restart Prevention and RatE STabilization in Atrial Fibrillation

Phase 4

• Conditions: Sick Sinus Syndrome; Brady-Tachy Syndrome

• Registration Number: NCT00224341
• Lead Sponsor: Vitatron France

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 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.

Study Timeline

• Study Start: 2003-11
• Status Verified: 2005-09
• Study First Submitted: 2005-09-20
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-22
• Last Update Submitted: 2006-10-17
• Last Update Posted: 2006-10-18
• Study Completion: 2006-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Patient with documented atrial fibrillation: at least one episode of paroxysmal AF documented 6 months prior to inclusion, lasting more than one minute
• Patient with a brady-tachy syndrome or a sick sinus syndrome, with a permanent pacing indication
• Atrial lead with a tip-to-ring interval equal to or less than 12 mm
• Patient who agrees with and has signed the informed consent

Exclusion Criteria

• Permanent AF
• AF related to a reversible cause
• One electrical cardioversion 6 months prior to inclusion
• Unstable angina
• Myocardial infarction (MI) less than 3 months
• Planned cardiac surgery or performed in the last 3 months
• Congestive heart failure, New York Heart Association (NYHA) class IV
• Life expectancy less than 18 months
• Patient participating in other studies
• Patient not able to follow the FU calendar
• Less than 18 years of age
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (19)

CMCO; 🇫🇷 Schiltigheim, France

Polyclinique Saint Laurent; 🇫🇷 Rennes, France

Institut Arnalt Tzanck; 🇫🇷 Saint Laurent du Var, France

CHU; 🇫🇷 Saint Etienne, France

CH René Pleven; 🇫🇷 Dinan, France

CH Saint Philibert; 🇫🇷 Lomme, France

Hopital Cardiologique du Haut Leveque; 🇫🇷 Pessac, France

Hopital Privé Claude Galien; 🇫🇷 Quincy-sous-Sénart, France

CH Toulon; 🇫🇷 Toulon, France

Hopital Privé; 🇫🇷 Antony, France

Clinique de la Casamance; 🇫🇷 Marseille, France

CHU La Timone; 🇫🇷 Marseille, France

Clinique Ambroise Paré; 🇫🇷 Neuilly sur Seine, France

Clinique de Bordeaux Cauderan; 🇫🇷 Bordeaux, France

CH; 🇫🇷 Valenciennes, France

HIA Percy; 🇫🇷 Clamart, France

CHG; 🇫🇷 Abbeville, France

CMC Parly II; 🇫🇷 Le Chesnay, France

Clinique Bouchard; 🇫🇷 Marseille, France