Clinical trial NCT00224341: Arrhythmia Restart Prevention and RatE STabilization in Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Sick Sinus Syndrome
Brady-Tachy Syndrome
Keywords: Pacemaker
Atrial Fibrillation
Prevention pacing
Algorithms
Sick sinus syndrome + Atrial Fibrillation
Lead sponsor: Vitatron France
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
measure: In a configuration including all the preventive pacing therapies of the device
measure: The primary endpoint is the atrial fibrillation burden.
Secondary outcomes:
measure: 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
measure: Nb of cardioversions
measure: Symptom score
measure: Restarts
measure: Daily incidence of AF
measure: Mean sinus rhythm duration
measure: 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
Other outcomes:
Locations:
city: Abbeville
country: France
facility: CHG
city: Antony
country: France
facility: Hopital Privé
city: Auxerre
country: France
facility: CH
city: Avignon
country: France
facility: CH
city: Bordeaux
country: France
facility: Clinique de Bordeaux Cauderan
city: Caen
country: France
facility: CHU
city: Castres
country: France
facility: CH
city: Clamart
country: France
facility: HIA Percy
city: Colmar
country: France
facility: CH
city: Dinan
country: France
facility: CH René Pleven
city: Dole
country: France
facility: CH
city: Dunkerque
country: France
facility: CH
city: Evreux
country: France
facility: CH
city: Grenoble
country: France
facility: CH
city: Le Chesnay
country: France
facility: CMC Parly II
city: Le Havre
country: France
facility: CH
city: Limoges
country: France
facility: CH
city: Lomme
country: France
facility: CH Saint Philibert
city: Marseille
country: France
facility: Clinique de la Casamance
city: Marseille
country: France
facility: Clinique Bouchard
city: Marseille
country: France
facility: CHU La Timone
city: Martigues
country: France
facility: CH
city: Metz
country: France
facility: CH
city: Montpellier
country: France
facility: CHU
city: Mulhouse
country: France
facility: CH
city: Neuilly sur Seine
country: France
facility: Clinique Ambroise Paré
city: Pessac
country: France
facility: Hopital Cardiologique du Haut Leveque
city: Quincy-sous-Sénart
country: France
facility: Hopital Privé Claude Galien
city: Rennes
country: France
facility: Polyclinique Saint Laurent
city: Rennes
country: France
facility: CHU
city: Rouen
country: France
facility: CHU
city: Saint Etienne
country: France
facility: CHU
city: Saint Laurent du Var
country: France
facility: Institut Arnalt Tzanck
city: Schiltigheim
country: France
facility: CMCO
city: Thionville
country: France
facility: CH
city: Toulon
country: France
facility: CH Toulon
city: Valenciennes
country: France
facility: CH
Study officials:
affiliation: CNOM
name: Patrick Attuel, MD
role: PRINCIPAL_INVESTIGATOR
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