Physiologically Guided Ablation of Reentry-Vulnerable-Zones for the Treatment of Post-Infarction Ventricular Tachycardia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 主要终点
- Composite of VT recurrence or death
研究概览
简要总结
The purpose of this study is to determine the efficacy of VT ablation guided by functional evaluation of the substrate to specifically target the reentry-vulnerable zones in patients with infarct-related VT.
详细描述
Activation mapping of VT is the gold-standard method for description of the reentrant circuit and identification of its isthmus, however this is uncommonly accomplished due to hemodynamic non-tolerance and limited temporal and spatial resolution. Substrate mapping has been developed as an alternative method to identify the isthmus of post-infarction VT during sinus rhythm (SR). However, it has limited specificity to critical VT sites.
Fundamental work in animal models of healed infarction and humans has shown that the VT isthmus corresponds to locations characterized by marked activation slowing during SR. Furthermore, these locations serve as "anchors" for multiple VT morphologies and cycle lengths.
The hypothesis of this study is that activation mapping during SR or pacing can improve the specifically for identifying the critical VT sites.
The aim of this prospective, multi-center controlled study is to evaluate the utility and limitations of functional mapping for guiding ablation of reentry vulnerably zones for long-term control of VT
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •History of myocardial infarction ≥1month before enrolment documented by ECG or cardiac imaging (TTE, SPECT, CMR).
- •Planned for first VT ablation procedure.
- •Patients must have an ICD or a plan for ICD implantation after the ablation.
- •Ability to understand the requirement of the study and to sign an informed consent.
排除标准
- •Patients requiring long-term treatment with class I or class III antiarrhythmic drugs after ablation (for AF).
- •The VT substrate is thought not to be related to coronary disease.
- •Presence of ongoing ischemia that is thought to be the cause of the VT.
- •Contraindication to anticoagulation therapy
- •Stroke within 30 days before enrollment.
- •Life expectancy <1 year for any medical condition.
研究组 & 干预措施
Study Arm
The left ventricle is mapped during atrial and right or left ventricular pacing (site close to the infarct) at a similar cycle length of 600ms. Radio-frequency ablation is performed selectively in areas of activation slowing (defined as ≤40ms per 5mm while voltage abnormalities and late potentials were not specifically targeted.
干预措施: Ablation (Device)
Control
Patient who underwent ablation using similar technology and irrigated catheters guided by standard substrate mapping techniques.
结局指标
主要结局
Composite of VT recurrence or death
时间窗: 36 months follow-up
次要结局
未报告次要终点