Database for predicting atrial fibrillation in patients with pacemakers and ICDs
SAFE-ME - Prospective Database for Prediction of Atrial Fibrillation in Pacemaker and ICD Patients
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 type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Graz Academic / other |
| Locations | 1 site (Graz) |
| Trial ID | NCT03357926 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Graz
- Medical University of Graz — Graz, Austria (Recruiting)
Study contacts
- Study coordinator: Daniel Scherr, Assoc.Prof. PD Dr.
- Email: daniel.scherr@medunigraz.at
- Phone: +4331638512544
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.