Health Consequences of the Burden of Atrial Fibrillation

Completed

• Conditions: Atrial Fibrillation; Burden

• Registration Number: NCT05389228
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

The Swiss-AF-BURDEN study will be embedded in the follow-up visits of the Swiss-AF cohort study. The research question of the current atrial fibrillation burden will be answered by using 7-day Holter-ECG recordings and continuous implanted loop recorder recording, whereas cardiac MRI examination will give results about cardiac dimensions and function. The 7-day Holter ECG will be repeated after one year. The cMRI will be performed separately or directly after the brain MRI to minimize the additional burden for the patients. Only a subsample of 100 patients will additionally receive ILR for 2 years.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2022-05-19
• Study First Submitted QC: 2022-05-19
• Study First Posted: 2022-05-25
• Primary Completion: 2024-01-07
• Study Completion: 2024-01-07
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 325

Inclusion Criteria

• Swiss-AF study patient
• Paroxysmal or persistent AF

Exclusion Criteria

• Permanent AF
• Swiss-AF patients not willing or able to undergo 7-day Holter monitoring
• Specifically for cMRI: Pregnant women or women of child-bearing age without a prior negative pregnancy test

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AF-burden	Baseline to Follow-up year 2	The burden of AF is defined as the amount of time (percentage) in AF during rhythm monitoring

Secondary Outcome Measures

Name	Time	Method
Incidence of overt and covert stroke	Baseline to Follow-up year 2	Number of participants with overt and covert stroke

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Switzerland