Sensitivity of the InSync Sentry OptiVol Feature for the Prediction of Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 501
- 试验地点
- 2
- 主要终点
- Prediction by OptiVol of HF-related Hospitalizations With Signs and/or Symptoms of Pulmonary Congestion.
研究概览
简要总结
The SENSE-HF study is a prospective, observational, international multi-center study prospectively evaluating the sensitivity and positive predictive value of the OptiVol Fluid Trends data in predicting Heart Failure related hospitalizations and health care utilizations associated with signs and/or symptoms of pulmonary congestion, and to define OptiVol clinical guidelines for subject therapy management.
详细描述
The SENSE-HF study prospectively evaluates the OptiVol feature in the prediction of Heart Failure related events associated with signs and symptoms of pulmonary congestion and in the subject HF therapy management.
The OptiVol feature is based on the measurement of daily intrathoracic impedance values, measurements that can be used to track changes in the subject's thoracic fluid status over time. An Alert warns the patient whenever a programmable threshold has been reached.
The study is divided into three phases.
The first phase is double-blinded and designed to determine the sensitivity and positive predictive value of the OptiVol Fluid Trends data for the detection of Heart Failure related hospitalizations with signs and/or symptoms of pulmonary congestion.
In the second phase of the study, the Alert is turned ON and the positive predictive value of the first OptiVol Patient Alert for the development of signs and/or symptoms of pulmonary congestion will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Double
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
- •Successfully implanted InSync Sentry device (< 34 days post implant or pocket revision)in the pectoral region;
- •At least one HF-related hospitalization that required administration of IV medication (inotropes, nitrates, diuretics) within the last 12 months
- •The Subject has a market released, transvenous, high voltage Right Ventricular lead
- •The Subject is able to detect a Patient Alert signal
排除标准
- •<18 years of age (or under a minimum age required by local law)
- •Moderate to severe Chronic Obstructive Pulmonary Disease (COPD)
- •Post heart transplant or awaiting heart transplantation
- •Primary pulmonary hypertension
- •Renal insufficiency requiring dialysis
- •Amendment to the inclusion criteria (Jul 06):
- •Inclusion of patients with Concerto/Virtuoso devices.
- •At least one HF-related hospitalization that required administration of IV (or uptitration of the oral medication)(inotropes, nitrates, diuretics)within the last 12 months
研究组 & 干预措施
Implantable Device diagnostics
All enrolled subjects were implanted with a device. Audible Device diagnostics turned on or off
干预措施: Implantable device: monitoring of intrathoracic impedance using the OptiVol diagnostic tool. (Device)
结局指标
主要结局
Prediction by OptiVol of HF-related Hospitalizations With Signs and/or Symptoms of Pulmonary Congestion.
时间窗: 34 days post device implant to 6 months
次要结局
未报告次要终点