NCT03536052已完成不适用
Ablation at Virtual-hEart pRedicted Targets for VT
适应症
干预措施
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
- Number of Participants With Ventricular Tachycardia Inducibility
研究概览
简要总结
The goal of this study is to test the efficacy of the new imaging/simulation ("virtual heart") approach for determining the optimal ablation sites in patients with VT, which render post-infarction VT non-inducible. The study will test both the acute outcome of the ablation procedure, and the effect the use of the predicted targets has upon procedure time.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible patients must be at least 18 years old at the time of enrollment.
- •A Pre-Op cardiac MRI including late gadolinium enhancement (LGE) must be performed prior to ablation. As Johns Hopkins University (JHU) performs MRIs with implantable cardioverter defibrillator (ICD) or pacemaker implanted, patients with these devices may be enrolled.
- •Eligible patients must suffer from VT, thought to be secondary to structural heart disease (scarring).
- •Eligible patients must be determined to be suitable candidates for ablation to treat VT by their cardiologist and/or electrophysiologists regardless of this protocol.
排除标准
- •Patients with Glomerular Filtration Rate (GFR) < 30 mL/min should not be enrolled in the study due to the use of intravenous gadolinium as an MRI contrast agent
- •If a pre-procedure MRI cannot or likely will not be performed for any reason (such as claustrophobia), the patient must be excluded.
- •Pregnant women may not participate in the study because gadolinium MRI contrast is contraindicated in these patients.
- •Any subject that, during the course of the pre-procedure imaging, is discovered to have VT not related to scarring, he/she must be de-enrolled from the study.
研究组 & 干预措施
Virtual Heart Guided Ablation
Experimental
干预措施: Virtual Heart Guided Ablation (Device)
结局指标
主要结局
Number of Participants With Ventricular Tachycardia Inducibility
时间窗: time of procedure
Following ablation, inducibility of VT will be determined using programmed electrical stimulation
次要结局
- Freedom From Ventricular Tachycardia(1 year)
研究者
研究点 (1)
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