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Recruiting NCT05790707

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

No phase Interventional Mild Cognitive Impairment Persistent Atrial Fibrillation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Atrial fibrillation ablation + antiarrhythmic drugs, Antiarrhythmic drug.
Who it may be relevant to
Registry conditions: Mild Cognitive Impairment, Persistent Atrial Fibrillation. Basic parameters: 60 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Procedure Atrial fibrillation ablation + antiarrhythmic drugs
    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.
  • Drug Antiarrhythmic drug
    Amiodarone, flecainide, sotalol, propafenone are the anti arrhythmic drugs allowed.

Primary outcome measures

  • Montreal Cognitive Assessmentquestionnaire score evolution 6 months [Time frame: baseline (randomization) and 6 months after randomization]
Secondary outcome measures (6)
  • Baseline characteristics associated with Montreal Cognitive Assessment score improvement [Time frame: baseline (randomization) and 6 months after randomization]
  • Changes in different types of cognitive functions [Time frame: baseline (randomization) and 6 months after randomization]
  • Montreal Cognitive Assessment questionnaire score evolution 12 months [Time frame: baseline (randomization) and 12 months after randomization]
  • Association between atrial fibrillation burden and cognitive function [Time frame: baseline (randomization) and 12 months after randomization]
  • Quality of life Short Form Survey (SF-12) [Time frame: baseline (randomization), 6 and 12 months after randomization]
  • Quality of life QOL-AD [Time frame: baseline (randomization), 6 and 12 months after randomization]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

France · 8 centers
  • CHU Angers — Angers
  • University Hospital — Brest
  • University Hospital — Caen
  • University Hospital — Dijon
  • CHU Grenoble — Grenoble
  • La Timone — Marseille
  • University Hospital — Poitiers
  • Centre Cardiologique du Nord — Saint-Denis

Identifiers

NCT: NCT05790707 · FALCON study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗