Low Energy Therapy Application to Convert Ventricular Tachycardias (LEVER)
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Conversion Efficacy of Low Energy VT Therapies
研究概览
简要总结
The LEVER study is a prospective, unblinded, non-randomized, first in human feasibility study that will assess and characterize early safety and effectiveness of low energy therapies in converting monomorphic ventricular tachycardias (MVTs).
详细描述
The LEVER study is a prospective, unblinded, non-randomized, first in human feasibility study that will assess and characterize early safety and effectiveness of low energy therapies in converting monomorphic ventricular tachycardias (MVTs). Subjects must be already indicated for standard of care VT procedure during which VT is likely to be induced (such as VT testing, VT ablation, VT mapping, or VT risk stratification testing.)
The study patches will be applied to the subject's torso, and the patches will be connected to the LEVER Acute Study System. Pacing capture threshold capture may be assessed. If monomorphic VT is induced and reaches at least 170bpm (350ms/cycle), one or more of the low energy therapies will be applied under oversight of the investigator, in an attempt to treat and convert the VT.
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
- •Subjects with a history of ventricular tachycardia indicated for ventricular testing procedures that may include VT induction, such as VT testing, VT ablation, VT mapping, or VT risk stratification testing.
- •Subjects age 18 or above, or of legal age to give written informed consent specific to local laws and requirements
- •Subjects who, in the opinion of the investigator, are suitable to be enrolled in a clinical study
排除标准
- •Subjects with any comorbidities that, in the opinion of the investigator, would exclude them from standard of care VT testing
- •Subjects with VT that is known to be focal in nature
- •Subjects whom the investigator believes are not hemodynamically stable enough to tolerate testing
- •Subjects of childbearing age who may be pregnant.
- •Subjects who are unwilling or unable to provide written informed consent.
- •Subjects with any implanted device that emits electrical energy where either therapy cannot be temporarily disabled, or the subject cannot tolerate temporary disabling of therapy.
研究组 & 干预措施
Acute Testing
Single-arm study - all subjects who meet the I&E criteria, sign the consent form and have inducible VT within the protocol-specified criteria may be tested for VT conversion with the LEVER Acute Study System.
干预措施: LEVER Acute Study System (Device)
结局指标
主要结局
Conversion Efficacy of Low Energy VT Therapies
时间窗: Acute - eg within 5 seconds of test therapy delivery
Effectiveness of LEVER Acute Study System low energy therapies to convert MVTs will be collected and tracked as an aggregate success rate (%) on a per-attempt basis for each therapy tested.
System and Procedure Related Adverse Events
时间窗: 7 days post-procedure
All system and procedure-related adverse events through 7 days (-1/+3 days) post-procedure will be collected and tracked.
次要结局
未报告次要终点