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

NCT03357926 | Recruiting

• 1 other identifier: 29-229 ex 16/17
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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).

Conditions

Atrial Fibrillation; Pacemaker Ddd; ICD

Outcome Measures

Primary Outcomes (1)

• Frequency of occurrence of atrial high rate episodes

  6 months

Study Arms (1)

Observation Group

Diagnostic Test: 24 hour Holter ECG Monitoring

Interventions

24 hour Holter ECG Monitoring DIAGNOSTIC_TEST

24 hour Holter ECG Monitoring

Observation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• pacemaker or ICD malfunction
• atrial fibrillation (AF) at time of pacemaker / ICD interrogation
• AF during 24-hour Holter ECG monitoring
• permanent AF

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz

Graz, 8036, Austria

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Daniel Scherr, Assoc.Prof. PD Dr.

CONTACT

+4331638512544; daniel.scherr@medunigraz.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2017
• First Posted: November 30, 2017
• Study Start: March 1, 2017
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)