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SwissAF-BURDEN: Health Consequences of the Burden of Atrial Fibrillation

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Recruiting
CT.gov ID
NCT05389228
Collaborator
Swiss National Science Foundation (Other), Clinical Trial Unit, University Hospital Basel, Switzerland (Other), Swiss Heart Foundation (Other), University Hospital Inselspital, Berne (Other), University Hospital, Geneva (Other)
460
Enrollment
1
Location
62
Anticipated Duration (Months)
7.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    460 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Health Consequences of the Burden of Atrial Fibrillation - The Swiss-AF-BURDEN Study
    Actual Study Start Date :
    Aug 1, 2018
    Anticipated Primary Completion Date :
    May 31, 2023
    Anticipated Study Completion Date :
    Sep 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. AF-burden [Baseline to FU year 2]

      The burden of AF is defined as the amount of time (percentage) in AF during rhythm monitoring

    Secondary Outcome Measures

    1. Overt and covert stroke [Baseline to FU year 2]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years and Older
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Basel Basel Switzerland

    Sponsors and Collaborators

    • University Hospital, Basel, Switzerland
    • Swiss National Science Foundation
    • Clinical Trial Unit, University Hospital Basel, Switzerland
    • Swiss Heart Foundation
    • University Hospital Inselspital, Berne
    • University Hospital, Geneva

    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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Michael Kühne, Prof. Dr. med., University Hospital, Basel, Switzerland
    ClinicalTrials.gov Identifier:
    NCT05389228
    Other Study ID Numbers:
    • Swiss-AF-BURDEN
    First Posted:
    May 25, 2022
    Last Update Posted:
    May 25, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Michael Kühne, Prof. Dr. med., University Hospital, Basel, Switzerland
    Atrial Fibrillation
    Burden
    Additional relevant MeSH terms:
    Atrial Fibrillation

    Study Results

    No Results Posted as of May 25, 2022