Paced Electrogram Feature Analysis (PEFA) for Ablation Targeting in Ischaemic Ventricular Tachycardia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Appropriate ICD shock
研究概览
简要总结
Canadian multicentre prospective cohort study of 40 patients with ischaemic heart disease and therapy from an implantable cardioverter defibrillator (ICD).
详细描述
Paced Electrogram Feature Analysis is employed to elucidate VT isthmus sites and target Type I sites for ablation to prevent recurrent VT/VF.
The trial hypothesis is: catheter ablation employing PEFA will, in comparison to published data, reduce the composite outcome of death at any time, appropriate ICD shock, ventricular tachycardia storm or treated sustained ventricular tachycardia below the detection rate of the ICD or incessant VT for patients with prior myocardial infarction and sustained ventricular tachycardia or fibrillation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •greater than 18 years of age
- •Ischaemic heart disease and prior myocardial infarction (using the international definition of MI: Q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non-ischemic cause with documentation of prior ischaemic injury)
- •Eligible for catheter ablation as standard of care
- •Implantable Cardioverter Defibrillator
排除标准
- •Unable or unwilling to provide consent
- •Both mechanical aortic and mitral valve
- •LV thrombus,
- •NYHA class IV heart failure symptoms
- •Contraindication to heparin
- •Survival limited to <1 year in estimation of attending care team,
- •Prior VT ablation Exclusion to standard of care VT catheter ablation procedure such as
- •Active ischaemia (acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on ECG) or another reversible cause of VT (e.g. drug- induced arrhythmia), had recent acute coronary syndrome within 30 days thought to be due to acute coronary arterial thrombosis, or have CCS functional class IV angina. Note that biomarker level elevation alone after ventricular arrhythmias does not denote acute coronary syndrome or active ischemia.
- •Non-ischaemic cardiomyopathy because of reduced ablation success and PEFA has not been examined in the context of a non-ischaemic cardiomyopathy
研究组 & 干预措施
PEFA targeted substrate ablation
Use of PEFA strategy to identify and target VT isthmuses.
干预措施: PEFA VT ablation technique (Procedure)
结局指标
主要结局
Appropriate ICD shock
时间窗: 3 years
Time to first appropriate ICD shock - any time post procedure
All-cause mortality
时间窗: 3 years
a composite of death - any time post procedure myocardial infarction and sustained ventricular tachycardia or fibrillation.
Incessant VT
时间窗: 3 years
Time to incessant VT defined as a sustained ventricular arrhythmia which does not terminate despite appropriate external cardioversion/defibrillation or ICD antitachycardia pacing or shocks, or terminates but reinitiates within ≤5 seconds - any time post procedure
VT storm
时间窗: 3 years
Time to 3 or more episodes of VT within 24 hours - any time post procedure
Treated sustained VT below the detection rate of the ICD
时间窗: 3 years
Time to any sustained VT below the detection rate of the ICD; e.g. by external cardioversion, pharmacologic conversion, or manual ICD therapy - any time post procedure
次要结局
- Inducible for ventricular arrhythmia(3 years)
- Appropriate anti-tachycardia pacing (ATP) from ICD(3 years)
- Escalation and De-escalation of antiarrhythmic medication(3 years)
- Number of ventricular arrhythmia events(3 years)
研究者
Dr. Damian Redfearn
MB CHB MD MRCPI FRCPC Professor of Medicine, Kingston Health Sciences Centre
Queen's University