Health Consequences of the Burden of Atrial Fibrillation | NCT05389228

Studies
Health Consequences of the Burden of Atrial Fibrillation

NCT05389228

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Mar 19, 2024Actual

Enrollment

325Actual

Phase

Not provided

Conditions

Atrial Fibrillation
Burden

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2018Actual

Primary Completion Date

Jan 7, 2024Actual

Completion Date

Jan 7, 2024Actual

First Submitted Date

May 19, 2022

First Submission Date that Met QC Criteria

May 19, 2022

First Posted Date

May 25, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2024

Last Update Posted Date

Mar 19, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Michael Kühne, Prof. Dr. med., University Hospital, Basel, SwitzerlandPrincipal Investigator

Lead Sponsor

University Hospital, Basel, SwitzerlandOTHER

Collaborators

Name	Class
Swiss National Science Foundation	OTHER
Clinical Trial Unit, University Hospital Basel, Switzerland	OTHER
Swiss Heart Foundation	OTHER
Insel Gruppe AG, University Hospital Bern

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

325Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Basel		Basel			Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided