Heart Sounds Registry In Patients Using The Wearable Cardioverter Defibrillator (HEARIT-Registry) Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 705
- 试验地点
- 32
- 主要终点
- Observe the changes in the heart sounds measurement
研究概览
简要总结
To conduct a prospective, observational study to evaluate the non-interventional feasibility of using heart sounds measurements recorded by the LifeVest® Wearable Cardioverter Defibrillator (WCD) for monitoring clinical evidence of heart failure decompensation.
详细描述
To conduct a prospective, observational study to evaluate the non-interventional feasibility of using heart sounds measurements recorded by the LifeVest® Wearable Cardioverter Defibrillator (WCD) for monitoring clinical evidence of heart failure decompensation.
Participants will be adult (age ≥ 18 years) heart failure patients with an ejection fraction (EF) ≤ 35% and eligible to wear the WCD for at least 3 months.
An FDA-approved WCD will be prescribed for at least 3 months of use after hospital discharge.
This is a multi-center, prospective, observational study.
The study will enroll a total of 300 subjects, anticipating that at least 250 subjects will complete the study. A maximum of 50 sites will enroll patients into the study.
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
- •Patients who are prescribed the WCD ≤ 10 days post-discharge after hospitalization with Heart Failure (HF), with and ischemic or non-ischemic cardiomyopathy.
- •Patients who have an ejection fraction (EF) ≤ 35% at the time of WCD prescription.
- •Patients are anticipated to wear the WCD for at least 3 months.
- •The subject must be 18 years of age or older on the day of screening.
排除标准
- •Patients with pacemakers, an implanted cardioverter defibrillator (ICD), or a cardiac resynchronization therapy device.
- •Patients waiting for heart transplant.
- •Patients with known evidence of atrial fibrillation on their most recent ECG recording.
- •Patients currently hospitalized for acute myocardial infarction.
- •Patients with a planned revascularization within 30 days of screening.
- •Patients who are self-reporting to be pregnant.
- •Patients participating in another clinical study.
- •Patients not expected to live longer than 1 year.
- •For patients in the United States, those who are unable or unwilling to provide written informed consent in English.
- •For patients in Europe, those who are unable or unwilling to provide written informed consent in their country specific language or English.
结局指标
主要结局
Observe the changes in the heart sounds measurement
时间窗: 3 months
Observe the changes in the heart sounds measurement (recorded by the WCD) with clinical evidence of heart failure decompensation during the three month WCD treatment period.
次要结局
未报告次要终点