Isolation of Pulmonary Veins With PVAC GOLD in Elderly Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Recurrence of atrial fibrillation
研究概览
简要总结
It is a prospective, randomized and double-blind clinical trial involving an invasive technique for isolation of pulmonary veins (PVAC gold) in relation to clinical treatment during an one year of segment. The patients included have paroxysmal atrial fibrillation (aged 65 years and older) refractory to antiarrhythmic treatments that do not have structural and / or ischemic heart diseases. This trial employed quality of life scores prior to the study and during the sixth and twelfth month of the segment, electrocardiograms and holter of 24 hours. The proposed imaging tests was the transesophageal echocardiogram before each procedure. The cerebral MRI was performed in the 24 hours post invasive procedure and Angio-tomography of the pulmonary veins in the 6-month segment.
详细描述
Objective
Pulmonary vein isolation (PVI) for atrial fibrillation (AF) has become progressively safer and more effective with advances in single-shot devices. The aim of this study was to compare catheter ablation (CA) of second-generation pulmonary vein ablation catheter (PVAC) Gold technique versus clinical treatment in elderly patients (≥ 65 years old) with symptomatic paroxysmal AF (PAF) without structural heart diseases.
Methods: Prospective randomized study that selected consecutive patients with paroxysmal atrial fibrillation older than 65 years-old in two groups: (1) PVAC ablation group and (2) antiarrhythmic drugs therapy group. Primary outcomes were AF recurrences, progression to persistent AF forms. As secondary outcomes, changes in Mini-Mental State Examination and AF Quality of Life Score were accessed.This study doesn't include payment of participants. All patients signed the informed consent.
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
- Double (Care Provider, Outcomes Assessor)
盲法说明
At the time of patient recruitment, they were randomly assigned to ablation or medical therapy (antiarrhythmic drug arm) according to a 1:1 stratified randomization list locked into a computer system.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for isolation of pulmonary veins
- •Age >= 65 years old
- •Association with the following characteristics:
- •Symptomatic Atrial Fibrillation;
- •Sinusal Rhythm maintenance failure for at least 1 Antiarrythmic Drugs;
- •Diagnosis of Atrial Fibrilation on resting eletrocardiogram and/or 24h Holter.
排除标准
- •Prior Atrial Fibrillation ablation;
- •Atrial Fibrillation permanent and/or persistent;
- •Left atrial size > 55 mm;
- •Mechanical prothetic mitral valve replacement;
- •Presence of atrial thrombus;
- •Cardiac invasive procedure < 90 days;
- •Cerebral embolism < 6 months;
- •Hypertrophic cardiomyopathy;
- •Contraindications to antiocoagulation and cerebral MRI.
结局指标
主要结局
Recurrence of atrial fibrillation
时间窗: 1 year after ablation
Recurrence of atrial fibrillation during 1 year of follow-up
次要结局
- Occurrence of Asymptomatic Cerebral Embolism(1 year of follow-up)
- Quality of Life Assessment(1 year after ablation)
- Esophageal Ulcer(24 hours after pulmonary vein isolation)
研究者
Mauricio Ibrahim Scanavacca
Arrhythmia Clinical Unit Director
University of Sao Paulo General Hospital