Jewel Electrophysiology (EP) Lab Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Clinical Effectiveness of the Jewel
研究概览
简要总结
Single arm open label evaluation of the Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) defibrillation waveform in adult cardiac patients.
详细描述
The primary objective of this study is to demonstrate safety and clinical effectiveness of the Jewel, using a single transthoracic defibrillation shock to terminate life-threatening VT or VF.
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 of both genders of at least 18 years of age.
- •Subjects who are scheduled for a standard EP clinical procedure where fast VT or VF may spontaneously occur or may be induced.
排除标准
- •Subjects who may require sterile access to the right upper pectoral or lower left torso regions during the planned EP procedure.
- •Subjects who have taken amiodarone in the past 3 months.
- •Subjects with an existing unipolar pacemaker.
- •Subjects who exhibit a left ventricular ejection fraction (LVEF) less than 20% (as assessed by techniques such as echocardiography, magnetic resonance imaging, or radionuclide angiography) within the last 6 months.
- •Subjects who have been diagnosed with heart failure (Class IV) or experienced an acute heart failure exacerbation within the previous 30 days.
- •Subjects who exhibit unstable angina.
- •Subjects with atrial fibrillation with contraindication to anticoagulation or improper anticoagulation management.
- •Subjects who are participating in an investigational study of a drug, biologic, or device not currently approved for marketing.
- •Subjects who are allergic to or have had a known adverse reaction to medical adhesives.
- •Subjects who have active skin breakdown, erythema, or other signs of infection in the pectoral or torso regions where the study device is applied.
- •Subjects with a lower abdomen circumference of less than 68.5 cm or greater than 142 cm.
- •Females who are pregnant or breastfeeding, or planning to be pregnant in the next 12 months.
- •Subjects who cannot provide or have diminished capacity to provide informed consent.
- •Any condition that an Investigator believes would interfere with the intent of the study or is not in the best interest of the patient.
- •Any patient that according to the Declaration of Helsinki is unsuitable for enrollment.
研究组 & 干预措施
Treatment
Safety and Effectiveness
干预措施: Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Device)
结局指标
主要结局
Clinical Effectiveness of the Jewel
时间窗: Immediately following defibrillation with the study device.
The count of participants with successful single shock terminations of life-threatening VT or VF. (The endpoint would be achieved if the lower confidence limit exceeds the performance goal of 62% using a one-sided exact lower 97.4% confidence bound at one of three testing points.)
次要结局
未报告次要终点