Prospective Database for Prediction of Atrial Fibrillation in Pacemaker and ICD Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 24 hour Holter ECG Monitoring.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation, Pacemaker Ddd, ICD. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
SAFE-ME - Prospective Database for Prediction of Atrial Fibrillation in Pacemaker and ICD Patients
Overview
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).
Interventions
- Diagnostic test 24 hour Holter ECG Monitoring
24 hour Holter ECG Monitoring
Primary outcome measures
- Frequency of occurrence of atrial high rate episodes [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- 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 criteria
- pacemaker or ICD malfunction
- atrial fibrillation (AF) at time of pacemaker / ICD interrogation
- AF during 24-hour Holter ECG monitoring
- permanent AF
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Austria · 1 center
- Medical University of Graz — Graz
Identifiers
NCT: NCT03357926 · 29-229 ex 16/17