NCT02830750已完成不适用
A Multi Center Registry of Low- Fluoroscopy Atrial Fibrillation Ablation Using Electroanatomic Mapping Carto
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Atrial Fibrillation
研究概览
简要总结
Prospective data collection of patients undergoing Atrial Fibrillation Ablation.
详细描述
Clinicians who have experience using low dose fluoroscopy including use of Carto Mapping system will consent patients to allow data collection and a 12 month f/up visit to track adverse events. Clinicians will follow a protocol which will be similar to their standard of care for ablations.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient meets accepted AHA/ACC/HRS guideline indications for catheter ablation of paroxysmal or persistent AF
- •First or subsequent ablation procedures may be included
- •Age 18-75
排除标准
- •Known venous malformations or implanted instrumentation (IVC filter)
- •Known PV stenosis
- •Unable to provide consent
- •H/O mechanical mitral valve replacement (unable to rely on EA mapping only)
- •Documented left atrial thrombus
- •Prior ASD repair Pregnancy
- •NYHA >=3
- •EF less than 35%
- •CHF within 90 daysRecent MI or coronary revascularization within 90 days
- •NOTE: H/O implanted pacemaker or ICD with transvenous leads will NOT be an exclusion criteria, but we will track patients treated with pre-existing transvenous leads with the hypothesis that although fluoroscopy use will be higher in these patients compared to those without leads, but still lower than conventionally treated patients.
- •Patients who are undergoing non- standard of care ablations ie, Cyro or FIRM ablations
结局指标
主要结局
Atrial Fibrillation
时间窗: 12 months
Determine Atrial Fibrillation burden at 12 month visit by reviewing monitoring systems that capture this data
次要结局
- Fluoroscopic Usage(post operative)
研究者
Gerri O'Riordan
Direcetor of Clinical Resarch. CV Med
Stanford University
研究点 (2)
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