NCT04473963已完成不适用
A Randomized Controlled Study to Evaluate the Reliability of Electrographic Flow™ (EGF) Mapping Algorithm Technology to Identify Sources of Atrial Fibrillation and Guide Ablation Therapy in Patients With Persistent Atrial Fibrillation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cortex
- 入组人数
- 85
- 试验地点
- 8
- 主要终点
- Number of Participants With Acute Procedure Success
研究概览
简要总结
This study is to evaluate Electrographic Flow™ (EGF) mapping algorithm technology (Ablamap® Software).
详细描述
The objective of this study is to evaluate the reliability of Electrographic Flow™ (EGF) mapping algorithm technology (Ablamap® Software) to identify sources of atrial fibrillation and guide ablation therapy in patients with persistent atrial fibrillation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suitable candidate for intra-cardiac mapping and ablation of atrial arrhythmias.
- •Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law.
- •Subjects with a history of documented symptomatic, persistent or longstanding persistent atrial fibrillation < 36 months.
- •Subject agrees to comply with study procedures and be available (geographically stable) for follow-up visits for at least 12 months.
- •Treatment of atrial fibrillation with ablation therapy presenting with recurrent symptoms of atrial fibrillation (not applicable to De Novo subjects)
排除标准
- •Left atrial diameter > 5.5 cm.
- •Left ventricular ejection fraction (LVEF) < 35%.
- •Presence of intramural thrombus, tumor or abnormality that precludes vascular access, catheter introduction or manipulation.
- •Coagulopathy, bleeding diathesis or suspected procoagulant state.
- •Known allergies or intolerance to anticoagulant and antiplatelet therapies to be used in conjunction with the study or contrast sensitivity that cannot be adequately pre-treated prior to the ablation procedure.
- •Positive pregnancy test results for female patients of childbearing potential or breast feeding.
- •Acute or chronic medical condition that in the judgment of the investigator would increase risk to the patient or deem the patient inappropriate to participate in the study.
- •Mitral valve stenosis and/or severe mitral regurgitation.
- •Valvular atrial fibrillation.
- •Prosthetic valves.
- •New York Heart Association (NYHA) Class IV.
- •History of myocardial infarction (MI) within 3 months prior to procedure.
- •Atrial septal defect (ASD) or left atrial appendage (LAA) closure device.
- •Atrial fibrillation from a reversible cause (e.g., surgery, hyperthyroidism, sarcoidosis or pericarditis).
- •Life expectancy < 12 months based on medical history or the medical judgement of the investigator.
- •Presence of any transvenous pacing, Implantable cardioverter defibrillators (ICD), cardiac resynchronization therapy (CRT) leads.
结局指标
主要结局
Number of Participants With Acute Procedure Success
时间窗: During the Procedure
Acute Procedure Success is defined as successful elimination of significant sources of electrographic flow (EGF) through targeted radiofrequency ablation. EGF-identified sources are significant when their leading source activity is above threshold. Successful elimination is defined as reduction of the source activity of the leading source below threshold upon post-ablation remapping using EGF mapping.
Number of Participants With Serious Adverse Events Related to the Procedure Through 7 Days
时间窗: 7 days
Freedom from Serious Adverse Events (SAE) related to the procedure through 7 days following the index procedure.
次要结局
- Number of Electrographic Flow™ (EGF) Identified Sources With Consistent Location Across Subsequent EGF-Guided Procedures(Index Procedure until Recurrence Procedure)
- Number of Participants With 12-month Freedom From AF Recurrence(90 day - 12 months)
- Average EGF Source Ablations Per Patient(During the procedure)
- Total Duration of EGF Source Ablation Per Patient(During the procedure)
- Average Fluoroscopy Time Per Patient(During the procedure)
- Total Radiation Dose Per Patient(During the procedure)
- Total Procedure Time(During the procedure)
研究者
研究点 (8)
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