RecruitingNCT03357926

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

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


Sponsor

Medical University of Graz

Enrollment

250 participants

Start Date

Mar 1, 2017

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is building a database to identify which patients with a pacemaker or defibrillator (an implanted heart device) are most likely to develop an irregular heartbeat called atrial fibrillation in the future, using information collected from the device and standard risk scores. **You may be eligible if...** - You have an implanted pacemaker or implanted cardioverter defibrillator (ICD) with an electrical lead in the upper chambers of your heart - Your heart rhythm risk score (CHADS-VASc) is 2 or higher, meaning you have some stroke risk factors - Your heart is currently in a normal or pacemaker-driven rhythm - Your pacemaker is stimulating the upper heart chamber less than 50% of the time - The device shows few irregular rhythm episodes **You may NOT be eligible if...** - Your pacemaker or ICD is not working properly - You currently have atrial fibrillation - You were found to have atrial fibrillation on a 24-hour heart monitor - You have permanent (constant) atrial fibrillation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TEST24 hour Holter ECG Monitoring

24 hour Holter ECG Monitoring


Locations(1)

Medical University of Graz

Graz, Austria

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NCT03357926


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