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

Study acronym: SAFE-ME
StatusRecruiting
PhaseNot specified
Started

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Trial flagged as At Risk
Primary completion moved at least 11 months later Dec 2025 → Dec 2026
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Record History

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  1. Notable Primary and study completion pushed from Dec 2025 to Dec 2026
    • Eligibility criteria expanded, about 9 words
  2. Notable Primary and study completion dates: Dec 2024 to Dec 2025v7
  3. Notable Primary and study completion dates: Dec 2023 to Dec 2024v6
  4. Notable Primary and study completion dates: Dec 2022 to Dec 2023v5
  5. Notable Primary and study completion dates: Dec 2020 to Dec 2022v4
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  1. Minor Re-verified, no change to tracked fieldsv3
  2. Notable Primary completion date: Dec 2018 to Dec 2020
    • Study completion date: Mar 2019 to Dec 2020
    v2
  1. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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).
Trial Details
NCT Number NCT03357926
Lead Sponsor Medical University of Graz
Conditions
(from sponsor)
Atrial Fibrillation, Pacemaker Ddd, ICD
Related terms Atrial Fibrillation
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov