NCT00334451已完成不适用
Remote Active Monitoring in Patients With Heart Failure
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 891
- 试验地点
- 1
研究概览
简要总结
The RAPID-RF Registry aims to characterize LATITUDE® Patient Management's alert feature: LATITUDE Active Monitoring™ by evaluating type and frequency of alert notifications and alert-related medical interventions. This registry will also assess clinical outcomes including quality of life and New York Heart Association Class changes over time, mortality, hospitalizations and heart failure-related event rates.
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 current indications for a Guidant RF-enabled CRT-D device (e.g. CONTAK RENEWAL 3 RF family of CRT-D devices) which is compatible with the LATITUDE Communicator. Indications include: NYHA Class III, IV; EF of ≤ 35%; QRS duration of ≥ 120 ms; and optimized pharmacologic therapy
- •Patients who have an analog telephone line compatible with the LATITUDE Communicator. The LATITUDE Communicator must be placed within 8 feet of where they sleep for successful remote interrogations to occur.
- •Patients who receive the study components including the LATITUDE Communicator, weight scale, and blood pressure monitor
- •Patients who are willing and capable of providing informed consent prior to implant and willing to participate in the RAPID-RF Registry
- •Patients who remain in the clinical care of a RAPID-RF investigator at approved centers
排除标准
- •Patients who are expected to receive a heart transplant during the course of the study
- •Patients who have received or who will receive a tricuspid valve prosthesis during the course of the study
- •Patients who have previously received an implantable cardiac resynchronization device (e.g., biventricular pacemaker or biventricular ICD)
- •Patients whose life expectancy is less than 12 months
- •Patients who are currently enrolled in another observational registry or investigational study that could directly impact the treatment or outcome of the RAPID-RF Registry. Contact Guidant's Clinical Application Research Study (CARS) department to determine eligibility.
- •Patients who are younger than 18 years of age
- •Patients who are pregnant or plan to become pregnant during the study
- •Patients who are unable or refuse to comply with the protocol requirements
研究者
研究点 (1)
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