Clinical trial Recruiting at 1 site Observational Ages 18 and up

Database for predicting atrial fibrillation in patients with pacemakers and ICDs

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

Run by Medical University of Graz · NCT03357926 · Data updated 2026-11-12

This study is trying to see if data from patients with pacemakers or defibrillators can help predict the chances of them developing atrial fibrillation over six months.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment250 (estimated)
SponsorMedical University of Graz
Academic / other
Locations1 site (Graz)
StatusRecruiting
StartedMarch 1, 2017
Main results expectedDecember 2026
Study endsDecember 2026
Registry record updatedOctober 16, 2026
Trial IDNCT03357926 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include patients with an implanted pacemaker or ICD, a CHADS-VASc score of 2 or more, and who are in sinus rhythm or atrial paced rhythm.

Probably not a fit

Patients who have a malfunctioning pacemaker or ICD, or those with existing atrial fibrillation at the time of interrogation or during Holter monitoring will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to recruit 250 patients who have an implanted dual-chamber pacemaker or an implantable cardioverter defibrillator with an atrial lead. Participants will undergo 24-hour Holter ECG monitoring to gather clinical and device data, which will be used to assess the occurrence of atrial fibrillation (AF) over a six-month follow-up period. The goal is to develop predictive algorithms and potentially a risk score for AF based on the collected data, enhancing the ability to predict AF in individual patients.

Why it matters

Potential benefit: If successful, this study could lead to improved prediction of atrial fibrillation, allowing for better management and prevention of associated complications like stroke.

How similar studies have gone: While the approach of using continuous rhythm monitoring for AF prediction is established, the specific methodology and algorithm development in this study may provide novel insights.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Medical University of Graz
    Graz, Austria
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.