EfFect of Ablation of Persistent AtriaL Fibrillation on COgNitive Function in Individuals With Mild Cognitive Impairment

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-80
SponsorPoitiers University Hospital

About this trial

The goal of this clinical trial is to evaluate the effect of catheter ablation of persistent atrial fibrillation on cognitive function in patients with mild cognitive impairment. Participants will be randomized into antiarrhythmic drugs alone or atrial fibrillation ablation + antiarrhythmic drugs.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 60 to 80 years

Persistent atrial fibrillation

Patients with an indication for cardiac rhythm control.

Montreal Cognitive Assessment score between 18 and 25 points corresponding to mild cognitive impairment

Disqualifiers

Impossibility to perform the neuropsychological evaluation (communication problems such as hearing loss or aphasia, language barrier)

History of clinical stroke

Presence of a bruit at carotid auscultation or history of severe carotid stenosis

History or suspicion of neurodegenerative disease (Parkinson's disease, Alzheimer's disease, Huntington's disease and amyotrophic lateral sclerosis...), bipolar disorder, schizophrenia, severe depression or amyloidosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Atrial fibrillation ablation + antiarrhythmic drugs

    Procedure/Surgery

    Atrial fibrillation ablation will be performed with endovascular catheters and will be done either with radiofrequency, cryoballoon or pulsed field ablation. Amiodarone, flecainide, sotalol, propafenone are the anti arrhythmic drugs allowed.

  • Antiarrhythmic drug

    Drug

    Amiodarone, flecainide, sotalol, propafenone are the anti arrhythmic drugs allowed.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Atrial fibrillation + antiarrhythmic drugsExperimental treatment 1 intervention
Group B: Antiarrhythmic drugs aloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Montreal Cognitive Assessmentquestionnaire score evolution 6 months

To evaluate the effect of "atrial fibrillation ablation + antiarrhythmic drugs" on cognitive function as assessed by the change at the Montreal Cognitive Assessment questionnaire score between randomization (M0) and 6 months after randomization (M6), compared with "antiarrhythmic drugs alone" in patients with persistent atrial fibrillation associated with mild cognitive impairment. The Montreal Cognitive Assessment questionnaire score ranges from 0 to 30. A higher score indicates better cognitive performance.

Time frame
baseline (randomization) and 6 months after randomization

Secondary outcomes

1

Baseline characteristics associated with Montreal Cognitive Assessment score improvement

To define the baseline characteristics associated with Montreal Cognitive Assessment improvement between randomization (M0) and 6 months after randomization (M6) in patients with mild cognitive impairment and persistent atrial fibrillation undergoing atrial fibrillation ablation. The Montreal Cognitive Assessment questionnaire score ranges from 0 to 30. A higher score indicates better cognitive performance.

Time frame
baseline (randomization) and 6 months after randomization
2

Changes in different types of cognitive functions

To assess changes in different cognitive functions measured by a comprehensive neurocognitive assessment between randomization (M0) and 6 months after randomization (M6). The assessed tests are : Free recall/indexed recall 16, WAIS IV "digit memory" subtest, Rapid Frontal Efficiency Battery (BREF) score, Trail Making Test (TMT- GREFEX version), Verbal fluency (GREFEX version) categorical (animals) and literal (letter P), Oral naming of the BETL (Battery for the Evaluation of Language Disorders), STROOP test (GREFEX version), Rey figure, Processing speed index from the WAIS IV.

Time frame
baseline (randomization) and 6 months after randomization
3

Montreal Cognitive Assessment questionnaire score evolution 12 months

To evaluate the effect of "atrial fibrillation ablation + antiarrhythmic drugs" on cognitive function as assessed by the change at the Montreal Cognitive Assessment questionnaire score between randomization (M0) and 12 months after randomization (M12), compared with "antiarrhythmic drugs alone". The Montreal Cognitive Assessment questionnaire score ranges from 0 to 30. A higher score indicates better cognitive performance.

Time frame
baseline (randomization) and 12 months after randomization
4

Association between atrial fibrillation burden and cognitive function

To evaluate the association between atrial fibrillation burden and cognitive function as assessed by the change at the Montreal Cognitive Assessment questionnaire score between randomization (M0) and 12 months after randomization (M12). The Montreal Cognitive Assessment questionnaire score ranges from 0 to 30. A higher score indicates better cognitive performance.

Time frame
baseline (randomization) and 12 months after randomization

Other outcomes

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