Phased RF Evaluation of Acute Pulmonary Vein Isolation in Paroxysmal AF With New GENius UI and PVAC GOLD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 11
- 主要终点
- Measure rate of post-procedure asymptomatic cerebral embolic (ACE) as determined by MRI
研究概览
简要总结
PRECISION GOLD is a prospective, multi-center, single arm, unblinded interventional post market clinical study conducted in Europe. The purpose of the study is to evaluate asymptomatic cerebral embolic (ACE) lesions in subjects with symptomatic paroxysmal atrial fibrillation undergoing ablation with the Pulmonary Vein Ablation Catheter (PVAC) GOLD.
详细描述
10-12 centers in Europe will enroll up to 56 subjects who meet the inclusion/exclusion criteria and provide consent to participate in the study. Subjects will undergo an ablation for paroxysmal AF with the Medtronic PVAC GOLD (CE-Mark). To assess for ACE lesions, pre- and post-ablation procedure cerebral MRIs will be done along with a neurological exam (Mini Mental State Exam). Subjects will be followed for 1 month post-procedure when a repeat MRI and neurological exam will be conducted if the subject had a positive MRI at pre-hospital discharge.
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
- •* Symptomatic AF (\>/=2 recurrent AF episodes that self terminate or AF \/=1 paroxysmal AF events within past year
- •* AF symptoms (e.g. palpitations, fatigue, exertional dyspnea, effort intolerance)
- •* Prescribed to vitamin K antagonist (e.g. warfarin/coumadin)
- •* Age 18-70 years old
- •* Clinically indicated for a pulmonary vein ablation
- •* Willing and able to give informed consent
- •* Willing, able and committed to participate in all study required activities for the duration of the study
排除标准
- •Diagnosis of persistent or permanent AF
- •Prior left atrial ablation
- •Presence of intracardiac thrombus
- •Contraindicated for vitamin K antagonist
- •Prescribed to direct thrombin or factor inhibitors (e.g. dabigatran, rivaroxaban)
- •Prescribed to any investigational drug that may confound the study results
- •Cardiac valve prosthesis
- •Significant congenital heart defect (corrected or not)
- •Pulmonary vein stents
- •Pre-existing pulmonary vein stenosis
- •Cerebral ischemic event (e.g. stroke, TIA) that occurred within 6 months of study consent date
- •If female - pregnancy
- •Participation in any other cardiovascular clinical study
- •Contraindicated for MRI
- •Active sepsis
- •Blood clotting abnormalities (genetic)
- •Presence of left atrial myxoma
- •Venous filtering device (e.g. Greenfield filter)
- •Invasive cardiac procedure in past 90 days
研究组 & 干预措施
Ablation / MRI
All subjects will undergo a standard of care ablation procedure for paroxysmal AF with the CE-Marked PVAC GOLD catheter.
MRIs will be performed on all subjects at Enrollment and Pre-Discharge (Post Ablation). Subjects with a positive MRI (cerebral lesion) at Pre-Discharge will undergo another MRI at the 1 month follow-up visit.
干预措施: Ablation / MRI (Other)
结局指标
主要结局
Measure rate of post-procedure asymptomatic cerebral embolic (ACE) as determined by MRI
时间窗: 1-45 days post-ablation procedure
Pre- and post-ablation MRIs will be evaluated for ACE lesions. If the post-ablation MRI (within 16-72 hours) is positive for ACE, a repeat MRI will be completed at the 1 month visit.
次要结局
- Measure acute procedural success(0-1 days after procedure)
- Report procedure and/or device related serious adverse events using PVAC GOLD(0-45 days post-ablation procedure)