Intracardiac Echocardiography Guided Slow Pathway Cryoablation for Treatment of Atrio-ventricular Nodal Reentry Tachycardia
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Noninducibility at the end of procedure
研究概览
简要总结
Atrioventricular nodal reentry tachycardia is best treated with catheter ablation aimed at disruption of conduction of the slow pathway. There are currently two possible options for this ablation: radiofrequency ablation and cryoablation. The first seems to result in superior success rate, however carries a small risk of collateral damage of the heart conduction system, specifically the atrioventricular (AV) node. Cryoablation seems less effective, but safer as AV nodal damage can be avoided. The aim of this study is to prospectively test possible improved efficcacy of cryoablation of the slow pathway with the use intraprocedural intracardiac echocardiography.
详细描述
We will prospectively enroll all patients that will be referred to our center for ablation of supraventricular tachycardia and will have an electrophysiologically proven atrioventricular nodal reentry tachycardia. In order to prove the mechanism specific maneuvers will be performed during induced sustained tachycardia. Navigation in the heart will be performed in a fluoroless fashion, with the use of a three-dimensional electro-anatomic mapping (3DEAM) system. Detailed anatomical definition and navigation in the area of the Koch triangle will be done with intracardiac echocardiography (ICE). Also, in sinus rhythm, when present, the Jackman potential will be tagged on the 3DEAM map. Cryomapping will be performed at the presumed location of the slow pathway (position of the Jackman potential or only anatomical location as defined with ICE) during ongoing tachycardia with the aim to terminate it and continue with cryoablation at the successful site.
Noninducibility will be tested with programmed and fast atrial stimulation. Patients will be followed clinically for up to 12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECG or holter ECG evidence of regular narrow QRS complex tachycardia, intraprocedural pacing maneuvers in sinus rhythm and during ongoing tachycardia indicating presence of AVNRT
排除标准
- •terminal or severe medical condition with expected survival of less then 12 months, deep venous thrombosis preventing access to the femoral vein, intracardiac thrombi, anatomical irregularities of pelvic veins and/or inferior vena cava, inability to induce AVNRT after the initial induction and diagnosis - enables exclusion of procedures where accidental mechanical termination of slow pathway conduction with the cryoablation catheter occurs
结局指标
主要结局
Noninducibility at the end of procedure
时间窗: up to 1 day
Noninducibility of AVNRT after cryoablation with programmed and fast atrial stimulation
Arrhythmia free survival
时间窗: 12 months
Absence of AVNRT episodes during follow-up
次要结局
未报告次要终点
研究者
Matevz Jan
MD
University Medical Centre Ljubljana