NL-OMON39982已完成不适用
Phased RF Evaluation of ACute Pulmonary Vein ISolation In ParOxysmal AF with New GENius UI and PVAC® Gold - PRECISION GOLD
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
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
- •Subject has Symptomatic paroxysmal AF defined as :
- •- Episodes of AF
- •- >=2 recurrent AF episodes that self-terminate, lasting no more than 7 continuous days
- •- episodes of AF <= 48 hours duration terminated with electrical or pharmacologic cardioversion
- •counts as a PAF episode
- •- Electrocardiographically documentation of one or more events with PAF (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, fatigue,
- •exertional dyspnea, effort intolerance;Subject is on a Vitamin K antagonist (i.e. Warfarin/Coumadin)
- •Subject between 18 and 70 years old
- •Subject is indicated for a pulmonary vein ablation
- •Subject is able and willing to give informed consent
- •Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study.
排除标准
- •Subject has persistent or permanent AF
- •Subject has had a prior left atrial ablation
- •Subject has a intracardiac thrombus
- •Subject is contraindicated for Vitamin K antagonist (i.e. Warfarin/Coumadin)
- •Subject is prescribed to direct thrombin or factor inhibitors (i.e. Dabigatran, Rivaroxaban)
- •Subject prescribed any investigational drug that may confound the study results
- •Subject has a cardiac valve prosthesis
- •Subject has a significant congenital heart defect corrected or not (including atrial septal defects or pulmonary vein abnormalities but not including minor PFO)
- •Subject has pulmonary vein stents
- •Subject has any pre-existing pulmonary vein stenosis
- •Subject has had a cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the Consent Date
- •Subject is a woman known to be pregnant
- •Participation in any other cardiovascular clinical study
- •Subject contraindicated for MRI
- •Subject has active sepsis
- •Subject has blood clotting abnormalities (genetic)
- •Subject has left atrial myxoma
- •Subject has a venous filtering device (Greenfield filter)
- •Subject has had an invasive cardiac procedure in the past 90 days
研究者
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