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

Sponsor

Medical University of Graz (Other)

Overall Status

Recruiting

CT.gov ID

NCT03357926

Collaborator

(none)

250

Enrollment

Location

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Pacemaker Ddd ICD	Diagnostic Test: 24 hour Holter ECG Monitoring

Study Design

Study Type:

Observational

Anticipated Enrollment :

250 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2017

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Observation Group	Diagnostic Test: 24 hour Holter ECG Monitoring 24 hour Holter ECG Monitoring

Arm

Intervention/Treatment

Observation Group

Diagnostic Test: 24 hour Holter ECG Monitoring

24 hour Holter ECG Monitoring

Outcome Measures

Primary Outcome Measures

Frequency of occurrence of atrial high rate episodes [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Graz	Graz		Austria	8036

Sponsors and Collaborators

Medical University of Graz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medical University of Graz

ClinicalTrials.gov Identifier:

NCT03357926

Other Study ID Numbers:

29-229 ex 16/17

First Posted:

Nov 30, 2017

Last Update Posted:

Sep 8, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Atrial Fibrillation

Study Results

No Results Posted as of Sep 8, 2021