ClinicalTrials.gg
RecruitingNCT03357926SAFE-MEUpdated Oct 16, 2026

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

An observational study in Atrial Fibrillation, Pacemaker Ddd and ICD, sponsored by Medical University of Graz. Recruiting at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by Medical University of Graz · Observational

From the registry’s dates

  • Started Mar 2017; still recruiting 9 years 8 months later.
Updated Oct 16, 2026Primary completion movedStudy completion movedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Atrial Fibrillation
  • Pacemaker Ddd
  • ICD

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03

In context

Atrial Fibrillation

4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.

This study's planned enrollment of 250 is below the median of 300 across 1,400 observational studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Medical University of Graz is the lead sponsor of 471 studies on the registry; 98 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with an implanted dual-chamber Pacemaker or an implantable cardioverter Defibrillator

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • pacemaker or ICD malfunction
  • atrial fibrillation (AF) at time of pacemaker / ICD interrogation
  • AF during 24-hour Holter monitoring
  • permanent AF
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (estimated)
Patient registry
No

Groups and cohorts

  • Observation Group

    Diagnostic Test: 24 hour Holter ECG Monitoring

Interventions

  • Diagnostic test24 hour Holter ECG Monitoring

    24 hour Holter ECG Monitoring

06

What researchers measure

Primary outcomes

  1. Frequency of occurrence of atrial high rate episodes

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Dec 2025→Dec 2026
Oct 16, 2026
Study completion
Dec 2025→Dec 2026
Oct 16, 2026
Show all 1 update
  1. Oct 16, 2026
    Primary completion Dec 2025→Dec 2026
    Study completion Dec 2025→Dec 2026
    + 3 other changes: verification date, site details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT03357926
Responsible party
Sponsor
First posted
Nov 30, 2017
Start date
Mar 1, 2017
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Oct 16, 2026

Study contacts

Daniel Scherr, Assoc.Prof. PD Dr.
Contact
daniel.scherr@medunigraz.at
+4331638512544

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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