NCT05201495已完成不适用
A Clinical Evaluation of the Jewel P-WCD in Subjects at High Risk for Sudden Cardiac Arrest
Element Science, Inc.60 个研究点 分布在 1 个国家目标入组 322 人开始时间: 2022年1月12日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 322
- 试验地点
- 60
- 主要终点
- Inappropriate Shock Rate
研究概览
简要总结
The Jewel IDE Study: A Clinical Evaluation of the Jewel P-WCD in Subjects at High Risk for Sudden Cardiac Arrest. ("JEWEL")
详细描述
Multi-center, prospective, single arm study of the Jewel Patch-Wearable Cardioverter Defibrillator (P-WCD) System in patients at high risk for Sudden Cardiac Arrest
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
- •Patients of any gender aged ≥ 18 years.
- •Patients with either:
- •a measured LVEF less than or equal to 40% (as assessed by techniques such as, but not limited to, cardiac angiography, echocardiography, magnetic resonance imaging, or radionuclide angiography within the last 30 days prior to enrollment) AND identified as presenting with a diagnosis of an AMI, ischemic cardiomyopathy (includes congestive heart failure: NYHA Class I - III), non- ischemic cardiomyopathy, or myocarditis;
- •who have a temporary or long-term contraindication to receiving an ICD, who have had an ICD removed, or who refuse an ICD
- •whose ICD implantation is delayed due to COVID-19 infection or exposure- related risks
排除标准
- •Member of a vulnerable patient population as defined in ISO 14155;
- •Life expectancy of less than one year, including end-stage heart failure, cancer, or other diagnosed condition;
- •Patients with an anticipated initial prescription period over 180 days (limitation only to allow timely closure of this clinical trial);
- •Patients with an advanced directive prohibiting resuscitation;
- •Existing ICD;
- •Existing unipolar pacemaker;
- •Existing FDA-cleared or FDA-approved active implantable or body worn medical device(s) that the Sponsor requires to be removed prior to the study but which cannot be removed;
- •Clinically significant valve disease, including aortic stenosis, mitral stenosis; mitral regurgitation, tricuspid regurgitation, insufficiency of the aortic or pulmonary valves, any of which is likely to require surgery in the next year;
- •A planned procedure, such as Coronary Artery Bypass Graft, within six (6) months;
- •End-stage renal disease, or chronic renal failure requiring hemodialysis;
- •Planned discharge to an institutional setting with an anticipated stay of greater than seven (7) days;
- •Having a mental, visual, physical, or auditory deficit, that could impair their ability to properly place, remove, or interact with the Jewel System;
- •Unable to understand English for the purposes of interacting with the device;
- •Unable to use a wearable defibrillator due to physical conditions (bandages preventing electrode contact, physical deformities preventing electrode contact, etc.);
- •Dextrocardia;
- •Body circumference of less than 27 inches or greater than 56 inches in the intended area of the Belt component of the Placement Accessory;
- •Participation in an investigational study of a drug, biologic, or device not currently approved for marketing;
- •Allergic to or have had a known adverse reaction to medical adhesives or hydrocolloids;
- •Active skin breakdown, erythema, or other signs of infection in the pectoral or torso regions where the Adhesive Electrode Patches are applied;
- •Females who are pregnant or breast-feeding, or planning to be pregnant in the next 12 months;
- •No US-based postal address that can be used to ship and receive study devices and supplies (a Post Office box is not an acceptable address for product shipments).
- •Patients who, in the opinion of the Investigator, are anticipated to be non-compliant with study instructions;
- •Unable to provide or have diminished capacity to provide informed consent;
- •Any condition that an Investigator believes would interfere with the intent of the study or make participation not in the best interest of the patient.
研究组 & 干预措施
Treatment
Experimental
Jewel Patch Wearable Cardioverter Defibrillator (P-WCD)
干预措施: Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Device)
结局指标
主要结局
Inappropriate Shock Rate
时间窗: Prescription Period during which each patient wore the Jewel up to 180 days.
Inappropriate shocks no more than 2.0 inappropriate shocks per 100 patient-months.
Cutaneous Adverse Device Effects
时间窗: Prescription Period during which each patient wore the Jewel up to 180 days.
Rate of subjects experiencing clinically significant cutaneous Adverse Device Effects of \< 15%
次要结局
未报告次要终点
研究者
研究点 (60)
Loading locations...
相似试验
已完成
不适用
Jewel Electrophysiology (EP) Lab StudySudden Cardiac ArrestNCT05490459Element Science, Inc.18
已完成
不适用
Safety and Performance Evaluation of WIRION™ EPD in Patients Undergoing Carotid Artery StentingCarotid Artery DiseasesStrokeNCT01783639Gardia Medical120
尚未招募
Unknown
Research about ICD for Primary preventioHeart failureJPRN-UMIN000053800St Marianna Univirsity50
已完成
不适用
IDUS in CBD Stone Recurrence High Risk PatientsCholedocholithiasisCholangiopancreatography, Endoscopic RetrogradeUltrasonographyNCT06265311Shanghai Municipal Hospital of Traditional Chinese Medicine248
已完成
3 期
Clinical Study for Patients With Hypertension Associated With DyslipidemiaHypertensionDyslipidemiaNCT01764295Daewoong Pharmaceutical Co. LTD.150