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Arrhythmia Restart Prevention and RatE STabilization in Atrial Fibrillation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Vitatron France.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Vitatron France
ClinicalTrials.gov Identifier:
NCT00224341
First received: September 20, 2005
Last updated: October 17, 2006
Last verified: September 2005

September 20, 2005
October 17, 2006
November 2003
Not Provided
  • 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.
  • Show clinical benefit of Post-AF Response and VRS algorithms, when combined, compared with a control group:
  • - In a configuration including all the preventive pacing therapies of the device.
  • The primary endpoint is the atrial fibrillation burden.
  • - In a conventional DDD configuration,
Complete list of historical versions of study NCT00224341 on ClinicalTrials.gov Archive Site
  • 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
  • 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.
Not Provided
Not Provided
 
Arrhythmia Restart Prevention and RatE STabilization in Atrial Fibrillation
Not Provided

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind
Primary Purpose: Prevention
  • Sick Sinus Syndrome
  • Brady-Tachy Syndrome
  • Device: Pacemaker Vitatron Selection 9000
  • Device: Pacemaker Vitatron T70
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
360
November 2006
Not Provided

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
Both
18 Years and older
No
Contact: Christèle Pelade, Engineer 01 53 98 83 00 christele.pelade@vitatron.com
Contact: Bérangère Leroy, Engineer 01 53 98 83 00 berangere.leroy@vitatron.com
France
 
NCT00224341
ARREST-AF
Not Provided
Not Provided
Vitatron France
Not Provided
Principal Investigator: Patrick Attuel, MD CNOM
Vitatron France
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP