Swiss Atrial Fibrillation Cohort Study

Atrial Fibrillation Clinical Trial

— SWISS-AF  

Official title:

Swiss Atrial Fibrillation Cohort Study - SWISS AF

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02105844
• Other study ID #: SWISS-AF
• Status: Active, not recruiting
• Start date: March 2014
• Est. completion date: March 2030

Study information

• Verified date: May 2024
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Swiss-AF is a prospective observational, multicentric cohort study in Switzerland. Overall, 2600 patients with documented atrial fibrillation aged >65 years will be included and followed on a yearly basis.

Yearly clinical examinations include a detailed questionnaire on personal characteristics, a resting electrocardiogram, neurocognitive function tests and questionnaires on disability and quality of life. Blood sampling and brain magnetic resonance imaging are scheduled at baseline and after 2 years of follow-up.

The main study aims of this long term prospective study are to increase our knowledge on structural brain damage and its changes over time in patients with atrial fibrillation, to gain additional insights on the incidence and underlying mechanisms of cognitive decline in patients with atrial fibrillation and to evaluate the interrelationships of structural and functional brain damage in this population.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2415
• Est. completion date: March 2030
• Est. primary completion date: March 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• atrial fibrillation documented within the last 24 months

• age >=45 years

Exclusion Criteria:

• acute illness

• inability to provide informed consent

• Only short episodes of reversible forms of atrial fibrillation

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Switzerland	University Hospital	Basel	Basel-Stadt

Sponsors (7)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Cardiocentro Ticino, Cardiovascular Research Institute (CRIB) Basel, Clinical Trial Unit, University Hospital Basel, Switzerland, Medical Image Analysis Center (MIAC) Basel, Schiller AG Baar, Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke or systemic embolism		2018 (after an average of 2.5 years of follow-up)
Secondary	Hospitalization for heart failure		2018 (after an average of 2.5 years of follow-up)