NCT03862339已完成不适用
UltraSOUND-based Characterization of Ventricular Tachycardia SCAR and Arrhythmogenic Substrate; The SOUNDSCAR Study
Liverpool Heart and Chest Hospital NHS Foundation Trust2 个研究点 分布在 2 个国家目标入组 38 人开始时间: 2018年11月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Areas of abnormal contraction (hypokinesia/akinesia) as determined by ICE imaging
研究概览
简要总结
Prospective, Non-randomized, Single-arm Study to assess the accuracy of intracardiac echocardiography (ICE) for characterization of arrhythmogenic substrate in patients with ischaemic cardiomyopathy undergoing ventricular tachycardia (VT) ablation
详细描述
ICE imaging during VT ablation is currently largely used for definition of cardiac anatomy. The role of the technique to specifically define scar and arrhythmogenic substrate has not been systematically evaluated. The aim is to assess the efficacy of the technique to accurately define the arrhythmogenic substrate.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior heart attack (myocardial infarction) with evidence from prior non-invasive imaging demonstrating regions of the heart with reduced heart muscle function (myocardial hypokinesia/akinesia/thinning) in the absence of a non-heart attack-related (non-ischaemic) cause
- •Age over 18 years
- •One of the following abnormal heart rhythm (VT) events within last 6 months:
- •≥3 episodes of VT treated with therapeutic rapid pacing from an implantable cardiac defibrillator (antitachycardia pacing [ATP])
- •≥1 appropriate shocks from an implantable cardiac defibrillator
- •≥3 episodes of abnormal heart rhythm (VT) within 24 hours
- •Sustained VT below the detection rate of the implantable cardiac defibrillator (documented by ECG/cardiac monitor)
- •Sustained abnormal heart rhythm (VT) in the absence of ICD which is documented by ECG/cardiac monitor
- •Patients in whom ICE imaging is planned for the clinical VT ablation procedure (clinical indication)
排除标准
- •Patient unable or unwilling to provide informed consent.
- •Acute heart attack (acute coronary syndrome with acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on ECG) or another reversible cause of abnormal heart rhythm (VT) - e.g. electrolyte abnormalities or drug-induced abnormal heart rhythms
- •Ineligible for ablation (known to have protruding clot in the chamber of interest (left ventricular thrombus), or have implanted mechanical aortic and mitral valves)
- •Had recent coronary bypass surgery (< 3 months) or percutaneous coronary intervention (<3 months)
- •Pregnant patients (pregnancy test will be performed in patients who are of childbearing age who are not on an effective contraceptive prior to all VT ablation procedures)
- •Had recent coronary bypass surgery (< 3 months) or percutaneous coronary intervention (<3 months)
结局指标
主要结局
Areas of abnormal contraction (hypokinesia/akinesia) as determined by ICE imaging
时间窗: 1 week
Area with abnormal contraction as correlated the findings on voltage mapping (low voltage) of the left ventricle in patients with a prior myocardial infarction undergoing VT ablation.
次要结局
- Areas of abnormal contraction as determined by ICE imaging(1 week)
研究者
研究点 (2)
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