Trial of Rapid Activation MaPping Using a nOveL Catheter and Integrated Non-invasivE Imaging in Ventricular Tachycardia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Correct identification of VT exit site
研究概览
简要总结
This non-randomised, prospective trial will examine the feasibility and efficacy of VT ablation guided by activation mapping using the Octaray and Optrell catheters. Annotation algorithms within the CARTO3 electro-anatomical mapping system will be integrated with 3D scar segmentation data from cardiac MRI (ADAS-VT), and extrastimulus voltage mapping will identify sites of interest for focussed activation mapping. The investigators hypothesise that the examination of these data will identify critical target sites for ablation. Intra-procedural diagnostic performance of the Octaray and Optrell catheters will be assessed as the primary outcome, and will be compared with the standard of care. Secondary, clinical outcomes - primarily the need for ICD therapies at 12 months post ablation - will be compared with propensity-matched controls undergoing substrate-based ablation alone. Follow-up MRI scans will review the impact of ablation on the elimination of conduction channels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICD in situ
- •Clinical indication for VT ablation; incessant VT or receiving appropriate ICD therapies for VT despite anti-arrhythmic drugs
- •Ischaemic or non-ischaemic heart disease
排除标准
- •Valvular heart disease precluding LV access
- •Cardiotomy within previous 3 months
- •Acute coronary syndrome within 6 weeks
- •Dialysis patients
- •Coagulopathy/Thrombocytopaenia
- •Pregnancy/breastfeeding women
- •CMR contraindicated
- •Prognosis <12 months
- •Unable to provide informed consent
研究组 & 干预措施
Octaray catheter
VT ablation guided by activation mapping using the Octaray catheter and integrated cardiac MRI data.
干预措施: Octaray catheter (Device)
Standard of care
Identified retrospectively from registry data: propensity matched-controls undergoing VT ablation guided by substrate-modification alone.
干预措施: Standard of care (Device)
结局指标
主要结局
Correct identification of VT exit site
时间窗: Intra-procedural
The site of VT origin suggested by activation mapping will be confirmed by either: i) Termination with ablation at this site ii) Entrainment of the tachycardia at this site (concealed fusion with PPI-TCL \<30ms and equivalent stimulus-QRS interval to EGM-QRS (30-70% TCL) interval) iii) Pace-mapping (average correlation coefficient \>90%)
Completeness of diastolic pathway recording
时间窗: Intra-procedural
The VT diastolic interval will be divided into temporal segments: i) First third: VT entrance ii) Middle third: VT isthmus iii) Final third: VT exit Completeness of diastolic pathway recording will be assessed according to the number of segments in which electrical activity is recorded
次要结局
- VT burden(12 months following VT ablation)
- Symptoms related to arrhythmia(12 months following VT ablation)
- Requirement for ICD therapies at 1 year(12 months following VT ablation)
- Morphological changes on serial cardiac MRIs(3 months following VT ablation)