Safety and Efficacy Aspects of a Standardized Stepwise Anatomical Approach for Atrio-Ventricular Nodal Re-entrant Tachycardia Ablation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Slow pathway modification/elimination
研究概览
简要总结
This proposal aims to evaluate safety and efficacy aspects of a new protocol for AVNRT ablation, using a stepwise anatomical approach.
The investigators hypothesize that the use of a standardized electro-anatomical guided strategy, using a sequential approach as follows:
- Right-side postero-septal tricuspid annulus
- Coronary sinus
- Left-side postero-septal mitral annulus
For slow pathway AVNRT ablation is safe and efficient, increasing the chance of a successful ablation in difficult cases, while reducing the need of re-do procedures and the risk for high-degree atrio-ventricular block.
The investigators aim to define and implement a new standardized protocol for AVNRT ablation while at the same time assessing the efficacy and safety of coronary sinus and left-side approaches for slow-pathway ablation.
详细描述
Atrio-ventricular nodal reentrant tachycardia (AVNRT) is the most common form of supraventricular tachycardia in adults. The substrate of AVNRT is dual nodal atrio-ventricular (AV) physiology represented by the presence of slow (SP) and fast pathway (FP) conduction. Selective radiofrequency (RF) ablation of the slow AV nodal pathway can cure the arrhythmia with acute success rates varying from 95 to 98% and low recurrence rates during long-term follow-up.
The compact AV node sends two posterior extensions with node-like tissue distributed towards the coronary sinus and tricuspid annulus (right posterior extension) and towards the mitral annulus (left posterior extension). Earlier literature suggested that the right posterior nodal extension is involved in the tachycardia circuit of most patients with AVNRT (slow pathway input). The tachycardia circuit may rarely involve the left posterior nodal extension, in which case a left-sided ablation procedure is needed. The right-sided approach is sufficient for the majority of cases and represents today the standard protocol for AVNRT ablation.
Lee et Al., in view of current anatomical and electrophysiological knowledge concerning the AV node, proposed the following sequential approach for SP ablation:
I. the isthmus between tricuspid annulus and coronary sinus ostium (the usual site of slow pathway), II. the tricuspid edge of coronary sinus ostium (by moving the ablation catheter tip slightly in and out of the coronary sinus), III. the septum lower than coronary sinus ostium, moving higher up on the half of Koch's triangle along the septum, IV. one or two burns inside the first few centimeters of the coronary sinus, V. left side of the septum (last).
The investigators hypothesize that the use of a standardized electro-anatomical guided strategy, using a sequential approach as follows:
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 and <80 years
- •History of symptomatic PSVT
- •Signed informed consent
- •Documented AVNRT during EPS with at least 1 of the following:
- •Previous unsuccessful right-sided ablation attempt
- •Ideal SP electrogram at XR < 10 mm in RAO 30°
- •Right-sided ablation attempt with:
- •VA block during JB or
- •A minimum of 7 unsuccessful RF energy deliveries, with no upper limit (to the 1st operator's discretion)
排除标准
- •Previous CVA
- •Severe mitral or aortic valve disease
- •Documented intra-cardiac thrombus
结局指标
主要结局
Slow pathway modification/elimination
时间窗: Up to 6 hours
Success of the ablation determined at the end of the procedure, defined as slow pathway modification (persistence of AH jump with maximum of 1 echo under Isoprenaline) or elimination (No AH jump; no echo), resulting in arrhythmia non-inducibility
次要结局
- High-degree AV block requiring permanent pace-maker(Up to 48 hours)
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(Up to 48 hours)
- Time to AVNRT recurrence(Up to 6 Months)
- Cardiac tamponade(Up to 48 hours)
- Systemic embolic events(Up to 48 hours)
- Transient AV conduction disturbance(Up to 48 hours)
- Peripheral arterio-venous complications(Up to 48 hours)