Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03357926

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

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).

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Graz

Graz, 8036, Austria

Location status: Recruiting

Location contact

Daniel Scherr, Assoc.Prof. PD Dr.

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

24 hour Holter ECG Monitoring

Diagnostic Test

24 hour Holter ECG Monitoring

Primary outcomes

  1. Frequency of occurrence of atrial high rate episodes

    Time frame: 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel Scherr, Assoc.Prof. PD Dr.

CONTACT

[email protected]

+4331638512544

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

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

Acronym: SAFE-ME

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Nov 30, 2017
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.