Atrial Fibrillation, Bradycardia
Conditions
Keywords
pacemaker, atrial fibrillation
Brief summary
Evaluation of dynamic Atrial Overdrive Stimulation using the AF Suppression Algorithm to prevent atrial tachyarrhythmias in patients with more than 2% Auto Mode Switch Episodes with optimized pacemaker programming. Hypothesis: Dynamic atrial Overdrive (AF Suppression) reduces AT/AF Burden by 30% as compared to programming DDDR-(60) without AF Suppression when all other parameters are optimized.
Detailed description
Atrial Fibrillation is the most common Heart Rhythm Disorder requiring therapy.
Interventions
DEVICEPacemaker Implantation
Implantation of a dual chamber pacemaker
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* indication for dual chamber pacemaker * documented paroxysmal or persistent Atrial Fibrillation * P-wave \>1.0 mV in Sinus Rhythm or sufficient detection of AFib * stable antyarrhythmic therapy * age \>= 19 years * written informed consent * implantation of a Identity DR 5370/5376 or later * bipolar atrial lead
Exclusion criteria
* permanent AFib * reversible etiology of AFib * HYHA II or IV * Coronary Artery disease with stable angina pectoris * implanted ICD or planned implantation of a ICD * cardiac surgery within the last 6 months or planned within 12 months * live expectancy \< 12 months * pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of AT/AF Burden in the pacemaker diagnostics | 12 months |
Countries
Germany
Outcome results
None listed