NCT02463851已完成不适用
PVAC GOLD Versus Irrigated RF Single Tip Catheter With Contact FORCE Ablation of the Pulmonary Veins for Treatment of Drug Refractory Symptomatic Paroxysmal and Persistent Atrial Fibrillation
L.V.A. Boersma6 个研究点 分布在 2 个国家目标入组 212 人开始时间: 2015年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 212
- 试验地点
- 6
- 主要终点
- Number of participants free of Atrial Fibrillation and not taking anti-arrhythmic drugs
研究概览
简要总结
The GOLD FORCE trial investigates the differences between treatment with a Contact Force single-tip catheter against the PVAC GOLD multielectrode catheter in cardiac ablation procedures in patients with paroxysmal atrial fibrillation.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of symptomatic paroxysmal atrial fibrillation defined as:
- •Self-terminating AF with episodes lasting no more than seven consecutive days before spontaneous conversion back to sinus rhythm
- •Documentation of one or more events with PAF tracings by ECG, event recordings, pacemaker strips or monitor rhythm strips within the past year
- •AF symptoms defined as the manifestation of any of the following:
- •Palpitations
- •Exertional dyspnea
- •Effort intolerance
- •Age between 18 and 70 Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study
排除标准
- •Structural heart disease of clinical significance including:
- •Previous cardiac surgery (excluding CABG)
- •Symptoms of congestive heart failure including, but not limited to, NYHA Class III or IV CHF and/or documented ejection fraction < 40% measured by acceptable cardiac testing
- •Left atrial diameter of > 45mm as measured in the parasternal long axis on transthoracic echocardiogram
- •LA volume>40 ml/m2
- •Stable/unstable angina or ongoing myocardial ischemia
- •Myocardial infarction (MI) within three months of enrollment
- •Aortic or mitral valve disease > Grade II
- •Congenital heart disease (not including ASD or PFO without a right to left shunt) where the underlying abnormality increases the risk of an ablative procedure
- •Prior ASD or PFO closure with a device using a percutaneous approach
- •Hypertrophic cardiomyopathy (LV wall thickness > 1.5 cm)
- •Pulmonary hypertension (mean or systolic PA pressure >50mm Hg on Doppler echo
- •Prior ablation for arrhythmias other than AF within the past three months
- •Prior left sided AF ablation
- •Enrollment in any other ongoing arrhythmia study protocol Any ventricular tachy-arrhythmias currently being treated where the arrhythmia or the management may interfere with this study
结局指标
主要结局
Number of participants free of Atrial Fibrillation and not taking anti-arrhythmic drugs
时间窗: Month 3 after intervention
次要结局
未报告次要终点
研究者
L.V.A. Boersma
Cardiologist
R&D Cardiologie
研究点 (6)
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