Predicting atrial fibrillation in people with pacemakers or defibrillators
Studies whether heart rhythm monitoring can predict atrial fibrillation in pacemaker or defibrillator patients.
Plain-language title generated from the registry record
Registry title: Prospective Database for Prediction of Atrial Fibrillation in Pacemaker and ICD Patients
Key facts
- Where
- Graz, AustriaSee the site
Where in Austria
- Medical University of GrazGraz, AustriaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medical University of Graz
- Trial code
- NCT03357926
- Record updated
- 16 October 2026
- Original description
Atrial fibrillation (AF) is associated with a five-fold increased risk of cerebrovascular stroke. While the risk of stroke in patients with known AF can be calculated via AF stroke prediction risk scores, the prediction of AF occurrence per se in individual patients remains difficult.Read full original descriptionShow less
SAFE-ME - Prospective Database for Prediction of Atrial Fibrillation in Pacemaker and ICD Patients
Atrial fibrillation (AF) is associated with a five-fold increased risk of cerebrovascular stroke. While the risk of stroke in patients with known AF can be calculated via AF stroke prediction risk scores, the prediction of AF occurrence per se in individual patients remains difficult.
We will recruit 250 patients with an implanted dual-chamber Pacemaker (PM) or an implantable cardioverter Defibrillator (ICD) with atrial lead to ensure continuous rhythm monitoring during follow up. At baseline, we will gather clinical and device data of patients. For AF prediction based on surface Electrocardiography (ECG), 24-h Holter ECG monitoring will be performed. After 6 months, we will assess the occurrence of AF during the study period via interrogation of PM/ICD. The resulting data will be used to develop algorithms including clinical, device and ECG data for prediction of the development of AF in individual patients. If possible, we will develop a risk score of high accuracy by combination of demographical, clinical and technical parameters of device patients. The resulting risk score could potentially help to facilitate the decision if anticoagulation is necessary in patients with either risk of AF or embolic stroke of unknown origin. Furthermore, Hayn et al. (AIT Austrian Institute of Technology) are currently developing algorithms to predict the occurrence of AF surface ECG data. It is an additional aim of this project to support the development of this algorithm in pacemaker and ICD patients and to increase the accuracy of AF prediction with clinical parameters and other parameters available to patients with implanted pacemaker (PM) or implanted cardioverter-defibrillator (ICD).
Inclusion: Implanted pacemaker or implanted cardioverter defibrillator (ICD) with atrial lead; CHADS-VASc Score of 2 or more; Sinus rhythm or atrial paced rhythm; Atrial stimulation rate 50% or less; ModeSwitch rate 50% or less since last pacemaker interrogation.
Exclusion: pacemaker or ICD malfunction; atrial fibrillation (AF) at time of pacemaker / ICD interrogation; AF during 24-hour Holter ECG monitoring; permanent AF.