Real-time Electrogram Analysis for Drivers of AtRial Fibrillation (RADAR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 8
- 主要终点
- Number of Participants With Atrial Fibrillation Termination
研究概览
简要总结
This prospective, multicenter, observational study will examine the ability of real time electrogram processing mapping to identify driver domains to target for ablation in persistent AF patients.
详细描述
ABSTRACT: Recent clinical trials have shown that targeting rotors and focal impulses (FIs) during atrial fibrillation (AF) ablation improves outcomes. This study evaluated whether a novel computational mapping algorithm (CMA) could identify FIs and rotors, and characterize rotors when incidental ablation resulted in rhythm changes. Three-dimensional (3D) left atrial electroanatomic maps were created from signals recorded from multipolar circular mapping catheters in 61 patients undergoing persistent AF ablation. Forty of 61acquired patient datasets were of adequate quality for analysis CMA, employing an AF pattern recognition algorithm, creating 3D panoramic AF maps identifying drivers of AF (FI and rotors) post procedure. Rotors were further classified as substrate (SBR) or non-substrate based (NSBR) on the basis of rotor stability, proximity to voltage transition zones and complex fractionated atrial electrograms (CFAEs). Incidentally ablated identified AF drivers, including SBRs and NSBRs, were evaluated for rhythm changes. A total of 172 drivers were identified in 40 patients (2.2 drivers/patient). Seventy percent were rotors (120/172) and 30% were FIs (52/172). Sixty-seven percent of rotors were classified as SBR vs 33% as NSBR. Incidental ablation of SBRs resulted in rhythm change 91% of the time versus only 24% of the time for NSBR (p<0.0001).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age.
- •Patients are considered eligible if they have symptomatic or drug-refractory AF and are planned to undergo a catheter ablation procedure for persistent AF (ether a first procedure or a redo procedure)
- •Ability to understand the requirements of the study and sign the informed consent form.
- •Willingness to adhere to study restrictions and comply with all post-procedural follow-up requirements
- •Projected lifespan greater than 1 year.
排除标准
- •They have long-standing persistent AF prior to the first procedure (defined as AF greater than one year's duration).
- •Rheumatic heart disease
- •Current intra-cardiac thrombus
- •History of MI or Coronary Artery Bypass Grafting (CABG) within 6 weeks
- •Unstable angina
- •CVA or TIA within 3 months
- •Contraindication to anticoagulation
- •Class IV HF
- •Unable to sign consent
- •Projected lifespan of < 1 year
- •Women known to be pregnant or to have positive beta-HCG (Human Chorionic Gonadotropin).
- •Participation in another study that would interfere with this study.
结局指标
主要结局
Number of Participants With Atrial Fibrillation Termination
时间窗: Day 1
Acute Procedural Outcomes as defined by termination of Atrial Fibrillation into normal sinus rhythm (NSR) or atrial tachycardia (AT)
Number of Participants Free From Recurrent AT/AF on no AAD
时间窗: at 12 months
Number of Participants freedom from recurrent Atrial Tachycardia/Atrial Fibrillation with no use of Anti-Arrhythmic Drugs (AAD)
Number of Participants Free From Recurrent AT/AF With no or Some AAD
时间窗: at 12 months
Number of Participants Free recurrent Atrial Tachycardia/Atrial Fibrillation with either some or no use of Anti-Arrhythmic Drugs
次要结局
- Duration of Fluoro Time(Day 1)
- Duration of Exposure(Day 1)
- Number of Procedure-related Adverse Events(up to 12 months)
- Rate of Post-ablation Inducibility of AF(Day 1)
- Duration of RF Ablation(Day 1)
- Number of Major Adverse Cardiac Events (MACE)(12 months)
- Number of Serious Adverse Events(12 months)
- Duration of Procedure Time(Day 1)
研究者
Vivek Reddy
Professor
Icahn School of Medicine at Mount Sinai