Comparative Study of Two 3D Electroanatomical Mapping Systems for Ablations of Different Complex Arrhythmias
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Procedure duration
研究概览
简要总结
Three dimensional anatomical mapping is an established method facilitating ablation of cardiac arrhythmias. The most commonly used systems are CARTO® System (Biosense Webster, Inc., Diamond Bar, CA, USA) and EnSite NavX™ (St. Jude Medical, Inc., St. Paul, MN, USA). These two systems has been compared in only a few studies. Recent technical advances resulted in the development of new versions of both systems. To the best of the investigators knowledge no studies have been performed for direct comparison of the newer versions of these two systems. The aim of the study to compare two systems for the use in the ablation of complex arrhythmias.
详细描述
Background:
Three dimensional anatomical mapping is an established method facilitating ablation of cardiac arrhythmias. It is nowadays an excepted method especially for complex arrhythmias such as atrial fibrillation and ventricular tachycardia.
The most commonly used systems are CARTO® System (Biosense Webster, Inc., Diamond Bar, CA, USA) and EnSite NavX™ (St. Jude Medical, Inc., St. Paul, MN, USA). These mapping systems have helped to decrease procedural complexity, procedure time, and improve safety. The EnSite NavX system uses impedance measurements between the individual catheter electrodes and the patches placed on the patient's chest and abdomen. The CARTO system utilizes magnetic location technology to provide accurate visualization of the magnet sensor-equipped catheter tip.
These two systems has been compared in only a few studies. Different results have been found in simple ablations versus more complex ablation of atrial fibrillation. Recent technical advances resulted in the development of new versions of both systems. Carto Express version allows quicker mapping and reconstruction of heart cavities and great vessels geometry as compared to previous versions of Carto XP. EnSite Velocity system incorporates more precise catheter visualization, and allows quicker mapping as compared to previous version of EnSite.
To the best of the investigators knowledge no studies have been performed for direct comparison of the newer versions of these two systems.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to sign informed consent.
- •History of one of the following arrhythmias requiring the use of 3D electroanatomical mapping:
- •Symptomatic paroxysmal or persistent atrial fibrillation with failed treatment of at least two anti-arrhythmic drugs.
- •Ischemic ventricular tachycardia necessitating ablation as per decision of electrophysiologist.
- •Symptomatic atrial tachycardia after failed medical treatment.
- •Symptomatic idiopathic ventricular tachycardia.
排除标准
- •Unstable patients not allowing performing procedure more than 2 hours
- •Patients planned for one of the two systems compared for whatever reason Ex. procedure planned with NAVX system Array Balloon).
结局指标
主要结局
Procedure duration
时间窗: Procedure duration - average expected 2.5 hours
Average procedure duration (needle to catheters withdrawal)
次要结局
- Fluoroscopy time(Procedures will be evaluated for the fluoro time, expected average 30 min)
- Procedure success(Patients will be followed for one year for recurrency of arrhythmia)
研究者
Gregory Golovchiner, MD
Principle Invistigator
Rabin Medical Center