NCT02026635撤回不适用
Cardiac Compass With Optivol® to Negate Future Inpatient Re-admissions Through Monitoring in Heart Failure Patients (CONFIRM-HF)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Physician Use of Cardiac Compass Reports to Determine HF Treatment Decisions
研究概览
简要总结
A research study to determine if heart failure can be medically managed using data collected from cardiac monitoring devices
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
- •At least 18 years of age
- •Admission for worsening of HF
- •Discharged to home
- •Have appropriate cardiac device with OptiVol® implanted for at least 34 days prior to enrollment
- •Enrolled in Carelink® system and able to transmit data
- •Able to participate for at least 3 months
排除标准
- •Post heart transplant or actively listed
- •End-stage (Stage D) HF, including treatment with chronic ionotropic drugs or left ventricular assist device support
- •Stage IV or V chronic renal dysfunction (GFR <25 mol/min per 1.73 M2)
- •Severe Chronic Obstructive Pulmonary Disease (COPD) requiring home oxygen
- •Severe pulmonary hypertension not due to left-sided HF
结局指标
主要结局
Physician Use of Cardiac Compass Reports to Determine HF Treatment Decisions
时间窗: 90 days from enrollment
Assessment will be completed at time of enrollment and days 3 to 7, 14 to 21, 30 and 90 post discharge.
次要结局
- Heart Failure Clinical Events(90 days from enrollment)
- Assess Patient-Reported Quality of Life(90 days from enrollment)
研究者
研究点 (1)
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