Health Consequences of the Burden of Atrial Fibrillation - The Swiss-AF-BURDEN Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 325
- Locations
- 1
- Primary Endpoint
- AF-burden
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
AF-burden
Time Frame: Baseline to Follow-up year 2
The burden of AF is defined as the amount of time (percentage) in AF during rhythm monitoring
Secondary Outcomes
- Incidence of overt and covert stroke(Baseline to Follow-up year 2)
Investigators
Michael Kühne
Prof. Dr. med.
University Hospital, Basel, Switzerland