EfFect of Ablation of Persistent AtriaL Fibrillation on COgNitive Function in Individuals With Mild Cognitive Impairment : - The FALCON Study-
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 8
- 主要终点
- Montreal Cognitive Assessmentquestionnaire score evolution 6 months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Atrial fibrillation + antiarrhythmic drugs
The ablation can be done with different sources of energy (radiofrequency, cryoballoon or pulsed field ablation). Different sets of lesions can be performed but the cornerstone is pulmonary vein isolation which will be mandatory.
Antiarrhythmic drugs management will be at the operator discretion. Some operators may stop antiarrhythmic drugs after atrial fibrillation ablation.
干预措施: Atrial fibrillation ablation + antiarrhythmic drugs (Procedure)
Antiarrhythmic drugs alone
Antiarrhythmic drugs available available are amiodarone, flecainide, propafenone, sotalol.
If not previously started, patients randomized to antiarrhythmic drugs arm should start antiarrhythmic drugs therapy within 1 week of randomization.
Apart from these recommendations, antiarrhythmic drugs management will be at the operator discretion.
干预措施: Antiarrhythmic drug (Drug)
结局指标
主要结局
Montreal Cognitive Assessmentquestionnaire score evolution 6 months
时间窗: 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.
次要结局
- Baseline characteristics associated with Montreal Cognitive Assessment score improvement(baseline (randomization) and 6 months after randomization)
- Changes in different types of cognitive functions(baseline (randomization) and 6 months after randomization)
- Montreal Cognitive Assessment questionnaire score evolution 12 months(baseline (randomization) and 12 months after randomization)
- Association between atrial fibrillation burden and cognitive function(baseline (randomization) and 12 months after randomization)
- Quality of life Short Form Survey (SF-12)(baseline (randomization), 6 and 12 months after randomization)
- Quality of life QOL-AD(baseline (randomization), 6 and 12 months after randomization)