NCT01900678已完成不适用
VLIC-USA: A Single-Center Study of the Safety and Efficacy of the VytronUS Low-Intensity Collimated Ultrasound Ablation System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Device or procedure related adverse events.
研究概览
简要总结
The objective of this investigation is to evaluate whether pulmonary vein isolation using the VytronUS ablation system is safe and effective acutely and at 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 70 years old.
- •Recurrent symptomatic paroxysmal atrial fibrillation refractory to at least one antiarrhythmic drug.
排除标准
- •Prior pulmonary vein isolation
- •Presence of intracardiac thrombus
- •Indication of inaccessible pulmonary or cardiac anatomy
- •Myocardial infarction, PCI, or cardiac surgery in prior three months
- •Moderate to severe valvular disease or prior valve replacement
- •NYHA Class IV
- •LVEF < 40%
- •Previous stroke or TIA
- •Serum creatinine > 2.5mg/dL or allergy to intravenous contrast agents
- •Existing bleeding diathesis or history of complications with anticoagulation therapy
- •Women who are nursing, pregnant, or trying to become pregnant
- •Subjects unwilling or unable to provide consent
- •Participation in a drug or device trial that would prevent completion of required study procedures
- •Active implantable devices
- •Major organ system disease
结局指标
主要结局
Device or procedure related adverse events.
时间窗: Three months post procedure.
次要结局
- Pulmonary vein isolation.(Three months post procedure.)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Study Comparing Pulmonary Vein Isolation With the Cryoballoon and Radiofrequency Energy(Contact Force) in the Treatment of Persistent Atrial Fibrillation (AF) (Cryo Vs CF in PerAF)Persistent Atrial FibrillationNCT03053570China Cardiometabolic Registries200
终止
不适用
Prophylactic Pulmonary Vein Isolation StudyAtrial FibrillationNCT00587899Mayo Clinic41
已完成
不适用
HeartLight Guided - Pure Pulmonary Vein Isolation Regardless of Concomitant Atrial SubstrateAtrial FibrillationNCT02655731Cardioangiologisches Centrum Bethanien100
已完成
不适用
CLOSE-guided Pulmonary Vein Isolation Using High Power and Stable RF ApplicationsAtrial FibrillationNCT04122963AZ Sint-Jan AV100
Unknown
4 期
Pulmonary Vein Isolation With Versus Without Continued Antiarrhythmic Drug Treatment in Subjects With Recurrent Atrial FibrillationAtrial FibrillationNCT02475642VZW Cardiovascular Research Center Aalst152