Arrhythmia Restart Prevention and RatE STabilization in Atrial Fibrillation
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|ClinicalTrials.gov Identifier: NCT00224341|
Recruitment Status : Unknown
Verified September 2005 by Vitatron France.
Recruitment status was: Recruiting
First Posted : September 22, 2005
Last Update Posted : October 18, 2006
|Condition or disease||Intervention/treatment||Phase|
|Sick Sinus Syndrome Brady-Tachy Syndrome||Device: Pacemaker Vitatron Selection 9000 Device: Pacemaker Vitatron T70||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||360 participants|
|Intervention Model:||Factorial Assignment|
|Study Start Date :||November 2003|
|Study Completion Date :||November 2006|
- 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.
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00224341
|Contact: Christèle Pelade, Engineer||01 53 98 83 email@example.com|
|Contact: Bérangère Leroy, Engineer||01 53 98 83 firstname.lastname@example.org|
|Principal Investigator:||Patrick Attuel, MD||CNOM|