Does asymptomatic Atrial Fibrillation lead to Cognitive Decline? An observational (non intervention) study of participants with Subclinical Atrial Fibrillation and possible decline in memory function.

Cognitive Decline in Subclinical Atrial Fibrillation. An observational prospective study characterising cognitive decline in patients with Subclinical Atrial Fibrillation.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12619001460190

Acronym

CogSAFe study

Enrollment

190

Registered

2019-10-22

Start date

2020-03-18

Completion date

2025-01-30

Last updated

2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The study explores the idea whether subclinical AF (SCAF) is associated with risk of dementia and is a longitudinal prospective study conducted over 3 years in patients with Cardiac Implantable Electronic Devices (CIED's) inserted. The study group will consist of 200 patients with SCAF and CHA2DS2-Vasc score (non-gender) of greater than or equal to 2. The control group will consist of 200 patients with documented absence of AF and CHA2DS2-Vasc score (non-gender) of greater than or equal to 2. All participants will undergo neurocognitive testing and quality of life questionnaires and optional brain Magnetic Resonance Imaging to assess for cerebral changes at study completion.

Interventions

Observational prospective longitudinal study. Exposed group: Patients presenting with device detected Subclinical Atrial Fibrillation will be assessed for Cognitive Function/Cognitive Decline over a period of 3 years. The AF burden greater than or equal to 0.5% and at least one episode greater than or equal to 6.0 hours during any 6 month period will be included in exposed group. Those with subclinical AF with burden less than specified will be followed up separately in a registry. Medical Records will be accessed by study staff to confirm eligibility for trial and study participation for all participants will involve an initial assessment by a Cardiologist who will perform pacemaker interrogation. This assessment is followed by an Echo cardiogram, cognitive assessments and quality of life surveys at enrollment and 3 years post enrollment. There is an optional blood test for Biomarker analysis at enrolment. MRI scans will be offered at 3 years post enrolment.

Eligibility

Sex/Gender

All

Age

60 Years to 85 Years

Healthy volunteers

Inclusion criteria

Patients undergoing a CIED implant or clinical review of previously implanted CIED in outpatients or private clinic Age 60-85 years old CHA2DS2-Vasc score (non gender) greater than or equal to 2

Exclusion criteria

Previously diagnosed Atrial Fibrillation Contraindication for Brain MRI Patients due to undergo Cardiac Implantable Electronic Devices replacement Valvular Severe Mitral Valve Disease Oral Anticoagulant Use Absent functional lead in pacemaker Parkinson's Disease Alzheimer's Disease Aphasia Severe Psychiatric Disorder An inability to provide informed consent

Outcome results