Health Consequences of the Burden of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— SwissAF-BURDEN  

Official title:

Health Consequences of the Burden of Atrial Fibrillation - The Swiss-AF-BURDEN Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05389228
• Other study ID #: Swiss-AF-BURDEN
• Status: Completed
• Start date: August 1, 2018
• Est. completion date: January 7, 2024

Study information

• Verified date: March 2024
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: January 7, 2024
• Est. primary completion date: January 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Burden

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (6)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Clinical Trial Unit, University Hospital Basel, Switzerland, Insel Gruppe AG, University Hospital Bern, Swiss Heart Foundation, Swiss National Science Foundation, University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AF-burden	The burden of AF is defined as the amount of time (percentage) in AF during rhythm monitoring	Baseline to Follow-up year 2
Secondary	Incidence of overt and covert stroke	Number of participants with overt and covert stroke	Baseline to Follow-up year 2