Prospective, Single Arm, Multi-center, Clinical Evaluation of the Ablacath™ Mapping Catheter and Ablamap® System Utilizing Electrographic Flow (EGF) Mapping to Resolve Extra-pulmonary Vein Sources of Atrial Fibrillation and Guide Ablation Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Cortex
- 入组人数
- 400
- 试验地点
- 48
- 主要终点
- Number of participants with 12-month freedom from AF recurrence (with or without AADs)
研究概览
简要总结
Demonstrate the safety and effectiveness of the Ablacath™ Mapping Catheter and Ablamap® System in patients with all types of atrial fibrillation (AF) including paroxysmal or persistent or long-standing persistent, undergoing and De Novo or Redo procedures.
Phenotype patients and demonstrate the prognostication power of Electrographic Flow (EGF®) maps among all subjects using 12-month follow-up outcomes following EGF-guided mapping and ablation.
详细描述
Subjects with all types of AF who are candidates for catheter ablation of their AF. The study will enroll up to 400 subjects in 25 centers globally.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 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 including atrial fibrillation, atrial flutter and/or atrial tachycardia
- •Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law
- •Left atrial (LA) diameter ≤ 5.5 cm or LA volume index ≤ 50 mL/m2 (use whichever measure is available or if both available, use the lesser of the two to qualify)
排除标准
- •De Novo paroxysmal AF
- •AF from a reversible cause (e.g., surgery, hyperthyroidism, sarcoidosis, or pericarditis, etc.)
- •Cardiac surgery or intervention within the past 90 days (e.g. percutaneous coronary intervention, ablation for ventricular arrhythmias, left atrial appendage occlusion devices, atrial septal defect closure devices, transcatheter aortic valve replacement)
- •Presence of transvenous pacing or defibrillator leads or an atrial leadless pacemaker
- •Myocardial infarction within the past 90 days
- •Severe valvular disease or prosthetic valve(s)
- •Contraindication to therapeutic anticoagulation
- •Decompensated heart failure or New York Heart Association (NYHA) Functional Class IV
- •Positive pregnancy test
- •Any other contraindication to an intracardiac mapping and ablation of atrial arrhythmias
- •Enrollment in another investigational study evaluating another device, biologic or drug
研究组 & 干预措施
De Novo Arm: Electrographic Flow (EGF) mapping
Subjects with persistent or long-standing persistent atrial fibrillation (AF), coming in for a De Novo pulmonary vein isolation procedure.
干预措施: Electrographic Flow (EGF) mapping (no ablation) (Device)
Redo Arm: Electrographic Flow (EGF) mapping and guided ablation of EGF-identified sources
Subjects with paroxysmal, persistent or long-standing persistent atrial fibrillation (AF) coming in for a redo AF procedure.
干预措施: Electrographic Flow (EGF) mapping and ablation of EGF-identified sources of Atrial Fibrillation (Device)
结局指标
主要结局
Number of participants with 12-month freedom from AF recurrence (with or without AADs)
时间窗: From 90 days to 12 months after index procedure
This measure represents the number of subjects with freedom from documented episodes of atrial fibrillation (AF) recurrence lasting longer than 30 seconds from the 90-day post-procedure blanking period through 12 months of follow-up (with or without AADs).
Number of participants with freedom from a composite of serious adverse events (SAEs) occurring within 7 days from the index procedure
时间窗: From index procedure to 7 days after index procedure
Evaluated by assessing combined rate of SAE composite as adjudicated by a CEC for relatedness to device or procedure
Demonstrate the predictive value of electrographic flow (EGF) phenotyping for ablation outcome
时间窗: 12 months
次要结局
- Number of participants with freedom from a composite of SAE occurring within 30 days from post-index ablation procedure(From index procedure to 30 days after index procedure)
- Overall reduction in burden of AF for subset of patients with implantable loop recorder(From 90 days to 12 months after index procedure)
- Overall procedure time, fluoro time, total EGF-guided mapping time, total EGF-guided ablation time(Index or Repeat Procedure)