Prevention of Atrial Fibrillation by Optimized Overdrive Stimulation
Not Applicable
Completed
- Conditions
- BradycardiaAtrial Fibrillation
- Registration Number
- NCT01912326
- Lead Sponsor
- Abbott Medical Devices
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 249
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Reduction of AT/AF Burden in the pacemaker diagnostics 12 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Universitätsklinikum Bonn AdöR
🇩🇪Bonn, Germany
Universitätsklinikum Bonn AdöR🇩🇪Bonn, Germany