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

March 15, 2024 updated by: Michael Kühne, University Hospital, Basel, Switzerland

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

Study Type

Observational

Enrollment (Actual)

325

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland
        • University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline to Follow-up year 2

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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