SAFE-ME - Prospective Database for Prediction of Atrial Fibrillation in Pacemaker and ICD Patients

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Austria
Medical University of Graz
RECRUITING
Graz
Contact Information
Primary
Daniel Scherr, Assoc.Prof. PD Dr.
daniel.scherr@medunigraz.at
+4331638512544
Time Frame
Start Date: 2017-03-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 250
Treatments
Observation Group
Related Therapeutic Areas
Sponsors
Leads: Medical University of Graz

This content was sourced from clinicaltrials.gov

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