Health Consequences of the Burden of Atrial Fibrillation

NCT ID: NCT05389228

Last Updated: 2024-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

325 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-01

Study Completion Date

2024-01-07

Brief Summary

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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.

Detailed Description

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Conditions

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Atrial Fibrillation Burden

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swiss National Science Foundation

OTHER

Sponsor Role collaborator

Clinical Trial Unit, University Hospital Basel, Switzerland

OTHER

Sponsor Role collaborator

Swiss Heart Foundation

OTHER

Sponsor Role collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role collaborator

University Hospital, Geneva

OTHER

Sponsor Role collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Michael Kühne

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Kuehne, MD Prof, exec MBA

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Laurent Roten, MD Prof

Role: PRINCIPAL_INVESTIGATOR

University Hospital Insel, Bern, Switzerland

Dipen Shah, MD Prof

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux Universitaires de Genève, Switzerland

Locations

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University Hospital Basel

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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Swiss-AF-BURDEN

Identifier Type: -

Identifier Source: org_study_id

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