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

Atrial Fibrillation Clinical Trial

— SAFE-ME  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03357926
• Other study ID #: 29-229 ex 16/17
• Status: Recruiting
• Start date: March 1, 2017
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Medical University of Graz
• Contact: Daniel Scherr, Assoc.Prof. PD Dr.
• Phone: +4331638512544
• Email: daniel.scherr[@]medunigraz.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• ICD
• Pacemaker Ddd

Intervention

Diagnostic Test:
• 24 hour Holter ECG Monitoring
24 hour Holter ECG Monitoring

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of occurrence of atrial high rate episodes		6 months