Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05790707

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Mild Cognitive Impairment Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Cognition Disorders Cognitive Dysfunction Heart Diseases Mental Disorders Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Persistent Atrial Fibrillation

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Angers, Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Free subject, not under temporary or permanent guardianship and not subject to subordination
  • Subject understanding and accepting the constraints of the study
  • Patient covered by French national health insurance or benefiting from it through a third party
  • Subject has given written consent to the study after having received clear and complete information

Exclusion criteria

  • 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
  • Patient with history of previous atrial fibrillation ablation
  • Patient undergoing flutter ablation or atrial tachycardia ablation (not atrial fibrillation ablation)
  • Contraindication to atrial fibrillation ablation (intracardiac thrombus, severe pulmonary hypertension, mechanical mitral valve prosthesis or contraindication to anticoagulation,…)
  • Contraindication to antiarrhythmic drugs, or to implantable cardiac monitor
  • Patient with very advanced persistent atrial fibrillation, i.e., for more than 3 years or with a left atrial diameter >60 mm in parasternal long axis section or a left atrial volume > 48ml/m2 in echocardiography
  • Subject with a life expectancy of less than 24 months at study enrolment
  • Inability to consent
  • Persons benefiting from a reinforced protection, namely minors, persons deprived of liberty by a judicial or administrative decision, adults under legal protection, and finally patients in emergency situations
  • Pregnant or breastfeeding women, women at age to procreate and not using effective contraception (hormonal/barrier: oral, parenteral, percutaneous implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total ovariectomy)

Treatment and study plan

Atrial fibrillation ablation + antiarrhythmic drugs

Procedure

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.

Primary outcomes

  1. Montreal Cognitive Assessmentquestionnaire score evolution 6 months

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

    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.

Secondary outcomes

  1. Baseline characteristics associated with Montreal Cognitive Assessment score improvement

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

    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.

  2. Changes in different types of cognitive functions

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

    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.

  3. Montreal Cognitive Assessment questionnaire score evolution 12 months

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

    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.

  4. Association between atrial fibrillation burden and cognitive function

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

    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.

  5. Quality of life Short Form Survey (SF-12)

    Time frame: baseline (randomization), 6 and 12 months after randomization

    To evaluate the effect of "atrial fibrillation ablation + antiarrhythmic drugs" on quality of life assessed by the change at the 12-Item Short Form Survey (SF-12) between randomization (M0), 6 and 12 months after randomization (M6 and M12), compared with "antiarrhythmic drugs alone". Score ranges from 0 to 100, with higher scores indicating better physical and mental health functioning.

  6. Quality of life QOL-AD

    Time frame: baseline (randomization), 6 and 12 months after randomization

    To evaluate the effect of "atrial fibrillation ablation + antiarrhythmic drugs" on quality of life assessed by the change at the Quality of life in Alzheimer's Disease (QOL-AD) questionnaire scores between randomization (M0), 6 and 12 months after randomization (M6 and M12), compared with "antiarrhythmic drugs alone". Score ranges from 13 to 52. The higher the score, the better quality of life the participant has.

Study contacts

Contact information is provided by the study sponsor or research team.

Rodrigue Garcia

CONTACT

[email protected]

549443729 ext. +33

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

EfFect of Ablation of Persistent AtriaL Fibrillation on COgNitive Function in Individuals With Mild Cognitive Impairment : - The FALCON Study-

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 30, 2023
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.