Comparative Evaluation of Optrell and Octaray Mapping Catheters for Conduction Block Confirmation and Voltage Assessment During Atrial Ablation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Concordance
研究概览
简要总结
This prospective, single-center observational study aims to compare the clinical performance, workflow efficiency, and electrophysiological metrics of two commercially available, high-density multielectrode mapping catheters (Octaray and Optrell) in patients undergoing catheter ablation for complex atrial arrhythmias.
The primary focus is to determine if the real-time vector propagation capabilities of the Optrell catheter combined with V8 software can accurately confirm conduction block across linear ablation lesions without the need for full-chamber activation remapping, which is the current standard of care. A secondary focus will pair-compare the bipolar voltage amplitude distributions recorded by both catheters, given their differing electrode sizes and spacing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Age ≥18 years.
- •• Documented persistent atrial fibrillation and/or atrial flutter.
- •• Undergoing a clinically indicated first-time (de novo) or redo catheter ablation where linear ablation lesion sets (e.g., posterior wall, roof line, lateral mitral line, CTI) are planned or anticipated.
- •• Ability to provide written informed consent.
排除标准
- •• Paroxysmal or persistent AF where only standard PVI is planned.
- •• Mechanical mitral valve.
- •• Presence of intracardiac thrombus or contraindication to systemic anticoagulation.
- •• Any medical condition or anatomical contraindication that, in the investigator's judgment, precludes safe participation.
- •• Pregnant women.
研究组 & 干预措施
Comparison between two mapping catheters, Optrell vs Octaray, in the same patient
干预措施: Atrial Fibrillation Radiofrequency Ablation Only (Device)
结局指标
主要结局
Concordance
时间窗: During ablation procedure
Percentage of agreement (presence vs. absence of bidirectional block) between the Optrell real-time vector assessment and standard activation remapping on a per-line basis.
Workflow Efficiency
时间窗: During ablation procedure
Difference in time (in minutes) required to confirm conduction block status using the Optrell vector method versus full activation mapping.
次要结局
- Bipolar Voltage Correlation(During ablation procedure)
- Multipolar Voltage Correlation(During ablation procedure)
- Clinical Efficacy(12 month follow up period)
研究者
Maxime Zabern
Cardiologist in Electrophysiology Unit
Assaf-Harofeh Medical Center