NCT03357926 Prospective Database for Prediction of Atrial Fibrillation in Pacemaker and ICD Patients
| NCT ID | NCT03357926 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Graz |
| Condition | Atrial Fibrillation |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2017-03-01 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2017-03-01 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03357926 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03357926 currently recruiting?
Yes, NCT03357926 is actively recruiting participants. Contact the research team at daniel.scherr@medunigraz.at for enrollment information.
Where is the NCT03357926 trial being conducted?
This trial is being conducted at Graz, Austria.
Who is sponsoring the NCT03357926 clinical trial?
NCT03357926 is sponsored by Medical University of Graz. The trial plans to enroll 250 participants.
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