Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,024
- 主要终点
- Occurrence of Heart Failure (HF) Related Adverse Event (AE)
研究概览
简要总结
The purpose of this study is to determine the value of diagnostic data obtained from Medtronic implantable cardioverter defibrillators (ICDs) with cardiac resynchronization therapy (CRT) to evaluate cardiovascular and heart failure related adverse events and health care utilization.
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 meet the ICD indications
- •Patients with Class III or IV heart failure.
- •Patients receiving or who received a Medtronic CRT ICD within the previous 3 months.
- •Patient must sign and date informed consent, and be 18 years of age or greater.
- •Patient must be available for follow up visits, and be willing and able to comply with study protocol.
排除标准
- •Patient with acute myocardial infarction (MI), coronary artery bypass graft surgery (CABG) or percutaneous coronary angioplasty (PTCA)/stent within the last month.
- •Patient with a mechanical right heart valve.
- •Patient with chronic (permanent) atrial arrhythmias.
- •Patient with life expectancy of less than 12 months.
- •Patient with status post heart transplant
- •Patient undergoing kidney dialysis
- •Patients enrolled in a concurrent study that may confound the results of the study.
结局指标
主要结局
Occurrence of Heart Failure (HF) Related Adverse Event (AE)
时间窗: From 6 month to the 12 month visit
Number of participates with HF realted adverse event will be reported. Time to the first HF related Adverse event in the "Follow-up Period" from the 6-month visit to the 12-month visit is compared between two risk groups. The goal was to test if there is a significant difference in time to first HF-related adverse event between two groups. A heart failure related (HF-related) adverse event is defined as an adverse event that results in a subject's worsening HF or related to the heart's inability to meet the metabolic demands of the body.
次要结局
- Occurrence of Heart Failure (HF) Related Healthcare Utilization (HU)(6 month to the 12 month visit)
- Occurrence of Heart Failure (HF) Related Pulmonary Congestion Event (PCE)(6 month to the 12 month visit)