Personalized Therapy Study - Heart Failure Risk Status (TriageHF) Post Approval Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Medtronic
- 入组人数
- 2,200
- 试验地点
- 92
- 主要终点
- positive predictive value (PPV) of HFRS High Risk Status associated with worsening heart failure
研究概览
简要总结
Medtronic is sponsoring the HFRS PAS to evaluate the HFRS feature (TriageHF) when used in routine clinical practice following commercial release. The HFRS PAS is conducted within Medtronic's Product Surveillance Registry (PSR) platform.
详细描述
The HFRS PAS is a global, prospective, observational, multi-site study. Patients implanted with a Medtronic Cobalt™ XT CRT (with Attain StabilityQuad™ MRI SureScan™ Model 4798 Lead (ASQ)) or ICD device who are enrolled in the Medtronic CareLink (CL) Network and the PSR will be followed per the standard of care practices of their care provider.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
- •Patient has or is intended to receive or be treated with an eligible ICD or CRT device or Patients may be enrolled pre-implant and up to 30 days post-implant following confirmation of patient eligibility.
- •Patient is enrolled in the Medtronic CareLink® Network for remote monitoring.
排除标准
- •Patient who is, or is expected to be inaccessible for follow-up
- •Patient with exclusion criteria required by local law
- •Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results.
结局指标
主要结局
positive predictive value (PPV) of HFRS High Risk Status associated with worsening heart failure
时间窗: Up to 5 years
To estimate the positive predictive value (PPV) of HFRS High Risk Status associated with worsening heart failure
次要结局
- Number of HF hospitalization or HF related deaths(Up to 5 years)