Atrial fibrillation Circulatory System Atrial fibrillation (AF)
Conditions
Interventions
Participants are randomised either to preventive pacing stimulation or to DDD[R]60-Stimulation.
Implantation of a triggered prevention pacemaker (Vitatron Selection 9000, Prevent AF, T
Sponsors
German Atrial Fibrillation Network
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Idiopathic paroxysmal symptomatic atrial fibrillation 2. Implantation of a fully functional pacemaker (e.g. normal impedance, stimulation thresholds and sensing values) Vitatron Selection 9000, Prevent AF, T 70 DR 2-4 months ago, because of one of the following indications: symptomatic sinus bradycardia, sinus arrest, Tachy-Brady-Syndrome 3. Symptomatic sinuatrial block 4. High-grade AV-Block (AV Block II und III) 5. Binodal disease: Sick-Sinus-Syndrome and high-grade AV-Block 6. AV-Nodal-Ablation in combination with a pacemaker therapy ('Ablate & Pace') 7. Written informed consent of the patient 8. Age >18 years
Exclusion criteria
Exclusion criteria: 1. Chronic heart failure (New York Heart Association [NYHA] III/IV) 2. Acute myocardial infarction <6 months 3. Hypertrophic obstructive cardiomyopathy 4. Symptomatic hypo- or hyperthyreosis 5. Instable angina pectoris 6. Cardiogenic shock 7. Patients with diabetes mellitus and recurrence of hypoglycaemia 8. Pregnancy or breast feeding 9. Participation in a clinical trial within the last 30 days. Simultaneous participation in a registry (e.g. project AB1 of the AFNET) is permitted. 10. Reduced life expectancy (<6 months) 11. Legal incapacity, or other circumstances which would prevent the patient from understanding the aim, nature or extent of the clinical trial 12. Evidence of an uncooperative attitude
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total of patients with a significant reduction (>25%) of AF burden in the 6-months-follow-up-period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. AF Burden 2. Total of patients without AF recurrence 3. Efficacy of pharmacologic treatment in preventive stimulation 4. Time in sinus rhythm 5. Time until first AF recurrence 6. Onset-Mechanism with and without medication 7. Total of patients who have a benefit from preventive stimulation 8. Proportion of atrial and ventricular stimulation 9. Safety of the therapy | — |
Countries
Germany
Outcome results
None listed