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Completed

NCT Number: NCT05389228

Health Consequences of the Burden of Atrial Fibrillation

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Burden Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Basel

Basel, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Incidence of overt and covert stroke

    Time frame: Baseline to Follow-up year 2

    Number of participants with overt and covert stroke

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

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

Registry information

Official study title

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

Acronym: SwissAF-BURDEN

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
May 25, 2022
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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