Prevention of Atrial Fibrillation by Optimized Overdrive Stimulation (PAFOS)
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Treatments
Details and patient eligibility
About
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.
Full description
Atrial Fibrillation is the most common Heart Rhythm Disorder requiring therapy.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
249 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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