NL-OMON36751已完成3 期
Multi-electrode PulmonarY Vein isolation vs Single Tip wide area Catheter ablation for Paroxysmal Atrial Fibrillation - MYSTIC-PAF
R&D Cardiologie0 个研究点目标入组 80 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1.History of symptomatic paroxysmal atrial fibrillation defined as:·
- •-Self-terminating AF lasting no more than seven days ·
- •-AF events demonstrating 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 year6 months·
- •-AF symptoms defined as the manifestation of any of the following
- •-Palpitations
- •-Exertional dyspnea
- •-Effort intolerance
- •2.Patient is refractory for at least 1 anti-arrhythmic drug
排除标准
- •1.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 > 50mm as measured in the parasternal long axis on transthoracic echocardiogram
- •-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)
- •2.Prior ablation for arrhythmias other than AF within the past three months
- •3.Cardioversion < 7 days before ablation procedure
- •4.Prior left sided AF ablation
研究者
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已完成
不适用
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