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Идёт набор NCT05790707

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

Без фазы С лечением Mild Cognitive Impairment Persistent Atrial Fibrillation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Atrial fibrillation ablation + antiarrhythmic drugs, Antiarrhythmic drug.
Кому может быть актуально
Состояния в реестре: Mild Cognitive Impairment, Persistent Atrial Fibrillation. Базовые параметры: 60 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Процедура 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.
  • Препарат Antiarrhythmic drug
    Amiodarone, flecainide, sotalol, propafenone are the anti arrhythmic drugs allowed.

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Франция · 8 центров
  • 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

Идентификаторы

NCT: NCT05790707 · FALCON study

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗