Isolation of Pulmonary Veins With PVAC GOLD in Elderly Patients (PVAC)
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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SP
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Sao Paulo、SP、巴西、05403010
- Arrhythmia Clinical Unit - Instituto do Coração - HCFMUSP
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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无干预：Clinical Treatment Group
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实验性的：Interventional Ablation Group
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Isolation of pulmonary veins using PVAC GOLD catheter.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Recurrence of atrial fibrillation
大体时间：1 year after ablation
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Recurrence of atrial fibrillation during 1 year of follow-up
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1 year after ablation
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Occurrence of Asymptomatic Cerebral Embolism
大体时间：1 year of follow-up
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Occurrence of Asymptomatic Cerebral Embolism during 1 year of follow-up
|
1 year of follow-up
|
|
Esophageal Ulcer
大体时间：24 hours after pulmonary vein isolation
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Esophageal Ulcer documented by Esophagus-gastro-duodenoscopy after ablation procedure
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24 hours after pulmonary vein isolation
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Quality of Life Assessment
大体时间：1 year after ablation
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Quality of Life in Atrial Fibrillation Questionnaire Score
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1 year after ablation
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合作者和调查者
合作者
调查人员
- 首席研究员：Mauricio I Scanavacca, MD, PhD、Arrythmia Clinical Unit Director
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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