Health Consequences of the Burden of Atrial Fibrillation (SwissAF-BURDEN)

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

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 Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Burden

• Study Type: Observational
• Enrollment (Actual): 325

Contacts and Locations

• Study Contact: Name: Michael Kuehne, MD Prof, exec MBA; Phone Number: +41613287471; Email: michael.kuehne@usb.ch
• Study Contact Backup: Name: Rebecca Paladini, PhD; Email: Rebecca.Paladini@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland
    • University Hospital Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients from the ongoing Swiss-AF cohort study with paroxysmal or persistent AF

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of overt and covert stroke	Number of participants with overt and covert stroke	Baseline to Follow-up year 2

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: University Hospital, Geneva; Swiss National Science Foundation; Swiss Heart Foundation; Clinical Trial Unit, University Hospital Basel, Switzerland; Insel Gruppe AG, University Hospital Bern
• Investigators: Principal Investigator: Michael Kuehne, MD Prof, exec MBA, University Hospital, Basel, Switzerland; Principal Investigator: Laurent Roten, MD Prof, University Hospital Insel, Bern, Switzerland; Principal Investigator: Dipen Shah, MD Prof, Hôpitaux Universitaires de Genève, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): January 7, 2024
• Study Completion (Actual): January 7, 2024

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; Burden
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: Swiss-AF-BURDEN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No