Comparative Evaluation of Optrell and Octaray Mapping Catheters for Conduction Block Confirmation and Voltage Assessment During Atrial Ablation
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.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Maxime Zabern, MD
- 电话号码：+972-54-5644963
- 邮箱：maximz@shamir.gov.il
研究联系人备份
- 姓名：Ofir Mitz
- 邮箱：ofirm@shamir.gov.il
学习地点
-
-
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Be’er Ya‘aqov、以色列
- 招聘中
- Shamir Medical Center
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接触：
- Maxime Zabern, MD
- 电话号码：+972-54-5644963
- 邮箱：maximz@shamir.gov.il
-
接触：
- Ofir Mitz
- 邮箱：ofirm@shamir.gov.il
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- • 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.
Exclusion Criteria:
- • 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Comparison between two mapping catheters, Optrell vs Octaray, in the same patient
|
Comparison between two mapping catheters, Optrell vs Octaray, in the same patient
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Concordance
大体时间：During ablation procedure
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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.
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During ablation procedure
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Workflow Efficiency
大体时间：During ablation procedure
|
Difference in time (in minutes) required to confirm conduction block status using the Optrell vector method versus full activation mapping.
|
During ablation procedure
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Bipolar Voltage Correlation
大体时间：During ablation procedure
|
Statistical correlation and evaluation of systematic bias (limits of agreement) between the bipolar voltage amplitudes recorded by the two catheters in matched anatomical regions.
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During ablation procedure
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Multipolar Voltage Correlation
大体时间：During ablation procedure
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Statistical correlation and evaluation of systematic bias (limits of agreement) between the multipolar voltage amplitudes recorded by the Optrell catheter and the bipolar voltage amplitudes recorded by the Octaray catheter in matched anatomical regions.
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During ablation procedure
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Clinical Efficacy
大体时间：12 month follow up period
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Freedom from any documented atrial tachyarrhythmia lasting ≥30 seconds at 1, 3, 6, 9, and 12 months
|
12 month follow up period
|
合作者和调查者
调查人员
- 首席研究员：Maxime Zabern, MD、Assaf-Harofeh Medical Center
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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