Reveal LINQ™ Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 19
- 主要终点
- Number of Participants With Reveal Device Experiencing an Initial Acute Decompensated Heart Failure (ADHF) Event
研究概览
简要总结
The purpose of the LINQ™ HF study is to characterize Reveal LINQ™ derived data from patients with heart failure by assessing the relationship between changes in LINQ™ derived data and other physiologic parameters with subsequent acute decompensated heart failure (ADHF) events.
详细描述
The study is a prospective, non-randomized, multi-center, observational, pre-market clinical study. The study is expected to be conducted at up to 30 centers in the United States. Up to 300 subjects will be enrolled to achieve approximately 40 heart failure events (no more than two per subject will contribute to the cumulative total). Study subjects will be followed for up to 3 years post-insertion or until official study closure defined as when Medtronic and/or regulatory requirements have been satisfied per the Clinical Investigation Plan and/or by a decision by Medtronic or regulatory authority, whichever occurs first. The expected study duration is approximately 4 years representing 1.5 years of enrollments and 2.5 years of follow-up.
The LINQ™ HF study is a Non-Significant Risk Investigational Device Exemption (IDE) study. The study is utilizing the Reveal LINQ™ device with an investigational LINQ™ HF RAMware download.
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
- •Patient is 18 years of age or older
- •Patient (or patient's legally authorized representative) is willing and able to provide written informed consent
- •Patient is willing and able to comply with the protocol, including follow-up visits and CareLink transmissions
- •Patient is NYHA Class III, per most recent assessment or at any time within 30 days prior to enrollment
- •Patient had a HF event (HF event defined as meeting any one of the following three criteria):
- •Admission with primary diagnosis of HF within the last 6 months, OR
- •Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at any one of the following settings within the last 6 months:
- •Admission with secondary/tertiary diagnosis of HF
- •Emergency Department
- •Ambulance
- •Observation Unit
- •Urgent Care
- •HF/Cardiology Clinic
- •Patient's Home, OR
- •Patient had the following BNP/NTpro-BNP within the last 3 months: If EF ≥ 50%, then BNP> 200 pg/ml or NTpro-BNP > 400 pg/ml OR If EF <50%, then BNP> 400 pg/ml or NTpro-BNP > 800 pg/ml
排除标准
- •Patient is pregnant (all females of child-bearing potential must have a negative pregnancy test within 1 week of enrollment)
- •Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager
- •Patient has severe valvular heart disease as defined by hemodynamically significant valve stenosis and/or prosthetic heart valve
- •Patient has existing IPG, ICD, CRT-D or CRT-P device
- •Patient has severe renal impairment (eGFR <25mL/min)
结局指标
主要结局
Number of Participants With Reveal Device Experiencing an Initial Acute Decompensated Heart Failure (ADHF) Event
时间窗: 30 days post-Reveal LINQ insertion to 3 years post-implant
A heart failure (HF) event is defined as any cardiovascular-related Health Care Utilizations (HCUs) for any one of the following events. * Admission with primary diagnosis of HF * Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at any one of the following settings: 1. Admission with secondary/tertiary diagnosis of HF 2. Emergency Department 3. Ambulance 4. Observation Unit 5. Urgent Care 6. HF/Cardiology Clinic Up to 2 ADHF events were intended to be allowed per subject: 1. One had to be at least 30 days post-Reveal LINQ insertion and is summarized in this section, and 2. A possible second ADHF event must be greater than 90 days after the first ADHF event Only subjects with a LINQ device were included in the analysis, as the goal was to acquire LINQ-collected data leading up to the ADHF event.
Number of Participants With a LINQ Device Experiencing a Second Acute Decompensated Heart Failure (ADHF) Events
时间窗: > 90 days following first Acute Decompensated Heart Failure event to 3 years post-implant
A heart failure (HF) event is defined as any cardiovascular-related Health Care Utilizations (HCUs) for any one of the following events. * Admission with primary diagnosis of HF * Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at any one of the following settings: 1. Admission with secondary/tertiary diagnosis of HF 2. Emergency Department 3. Ambulance 4. Observation Unit 5. Urgent Care 6. HF/Cardiology Clinic Up to two ADHF events per subject were intended to be evaluated. The first must be at least 30 days post-Reveal LINQ insertion, and the second, summarized in this section, must be greater than 90 days following the first ADHF event. Only subjects with a LINQ device were included in the analysis, as the goal was to acquire LINQ-collected data leading up to the ADHF event.
次要结局
未报告次要终点