NCT05389228

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
325

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 25, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2024

Completed
Last Updated

March 19, 2024

Status Verified

March 1, 2024

Enrollment Period

5.4 years

First QC Date

May 19, 2022

Last Update Submit

March 15, 2024

Conditions

Atrial FibrillationBurden

Keywords

Atrial FibrillationBurden

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Incidence of overt and covert stroke

    Baseline to Follow-up year 2

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Swiss-AF study patient
  • Paroxysmal or persistent AF

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, Switzerland

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

May 19, 2022

First Posted

May 25, 2022

Study Start

August 1, 2018

Primary Completion

January 7, 2024

Study Completion

January 7, 2024

Last Updated

March 19, 2024

Record last verified: 2024-03

Locations

CH(1)