Prospective Registry of Patients With Ischemic Heart Failure Using the LifeVest Wearable Cardioverter Defibrillator (WEARIT-III)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Number of clinical events in heart failure patients with ischemic cardiomyopathy prescribed wearable cardioverter defibrillator (WCD)
研究概览
简要总结
The WEARIT-III registry enrolls subjects with ischemic cardiomyopathy and heart failure (including NYHA II, III, IV and an ejection fraction ≤ 35%) who wear a medically prescribed ZOLL LifeVest Wearable Defibrillator. The primary objective of the WEARIT-III Registry is to prospectively document the clinical course of high-risk cardiac patients with heart failure and ischemic cardiomyopathy prescribed with Wearable Cardioverter Defibrillator (WCD), such as left ventricular function recovery, arrhythmia, Implantable Cardioverter Defibrillator (ICD), Cardiac Resynchronization Therapy (CRT), Left Ventricular Assist Device (LVAD), heart transplantation, and to assess the benefit of WCD in heart failure patients with ischemic cardiomyopathy.
详细描述
STUDY PROCEDURE
U.S. patients prescribed a commercially available WCD (ZOLL LifeVest) will be approached by a letter from the sponsor which summarized the study purpose and procedure. Once a patient signs a consent form to participate the study, he or she will receive three questionnaire from University of Rochester, the coordination and data center for the WEARIT registry, at the time enrollment, at 3 month and 12 month follow-up, respectively. At 3 and 12-month follow-up, the physician of the patient will be contacted to provide information on arrhythmias, and interim events (ICD, CRT or LVAD implantation, heart failure episode, death), and to send us related hospital reports and echocardiogram reports to assess the improvement in left ventricular function.
STUDY DESIGN
WEARIT-III is a prospective observational patient registry. Optimal pharmacologic and/or implanted device therapy is anticipated, and the Registry physicians will not be involved in any medical care of the subjects, only collecting information on the standard care of these patients. In WEARIT-III we will also retrieve hospital records/echocardiogram reports of the subjects during follow-up using an authorization form signed by the study subjects and contact their physician to collect information on improvement of the left ventricular function whenever it is available.
DATA MANAGEMENT, DATA STORAGE
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
- •Subjects of 18 years old or older;
- •Subjects who are recently diagnosed with heart failure of ischemic etiology (either revascularized or cannot be revascularized);
- •NYHA functional class II, III, or IVa (ambulatory);
- •Left ventricular ejection fraction ≤ 35%;
- •Subject wearing a prescribed ZOLL LifeVest WCD;
- •Subject agrees to enter the Registry after appropriate informed consent.
排除标准
- •Subjects who are unable or unwilling to cooperate with the study protocol;
- •Subjects who are not willing to participate;
- •Subjects who have acute ST-segment elevation myocardial infarction (STEMI) within 30 days before prescribed with WCD;
- •Subjects with cardiomyopathy from mixed etiology;
- •Subjects with active or previously explanted cardiac devices such as ICD, CRT or LVAD except for pacemaker;
- •Subjects with a life expectancy of less than a year, including end-stage heart failure, cancer and end-stage renal disease.
结局指标
主要结局
Number of clinical events in heart failure patients with ischemic cardiomyopathy prescribed wearable cardioverter defibrillator (WCD)
时间窗: 1 year
The primary objective of the WEARIT-III Registry is to prospectively document the clinical course of high-risk cardiac patients with heart failure and ischemic cardiomyopathy prescribed with WCD, such as left ventricular function recovery, arrhythmia, implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy (CRT), left ventricular assist device (LVAD), heart transplantation, and to assess the benefit of WCD in heart failure patients with ischemic cardiomyopathy.
次要结局
- All-cause mortality(1 year)
- Number of inappropriate shocks(1 year)
- WCD shock conversion success rate(1 year)
- NYHA functional class(At enrollment, 3-month and 1-year follow-up)