Arrhythmia Restart Prevention and RatE STabilization in Atrial Fibrillation
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 360
- Locations
- 56
- Primary Endpoint
- 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
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- Single
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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 Outcomes
- 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