Brady-Tachy Syndrome, Sick Sinus Syndrome
Conditions
Keywords
Pacemaker, Atrial Fibrillation, Prevention pacing, Algorithms, Sick sinus syndrome + Atrial Fibrillation
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.
Interventions
DEVICEPacemaker Vitatron Selection 9000
DEVICEPacemaker Vitatron T70
Sponsors
Vitatron France
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Restarts | — |
| Daily incidence of AF | — |
| 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 | — |
| 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 | — |
| Mean sinus rhythm duration | — |
| Nb of cardioversions | — |
| Symptom score | — |
Countries
France
Contacts
Primary ContactChristèle Pelade, Engineer
Backup ContactBérangère Leroy, Engineer
Outcome results
None listed