Integrated Diagnostic Evaluation in Non-Therapy DevIces For the studY of Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 22
- 主要终点
- Correlation of Heart Failure Risk Score (HFRS) With Heart Failure Events
研究概览
简要总结
The purpose of this study is to characterize the feasibility and impact of a diagnostic tool that may help clinicians identify when patients are at higher risk of visiting the hospital for a heart failure event. The study will use a non-experimental device that is inserted just under the skin of the chest, which continuously monitors the heart rhythm in combination with an experimental web-based heart failure risk status. Patients with atrial fibrillation and heart failure will be evaluated to collect data about the potential of this risk status to help improve patient outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Documented paroxysmal or persistent atrial fibrillation or strong suspicion of atrial fibrillation (i.e, palpitations)
- •Patient is indicated for the Reveal XT insertable cardiac monitor or other commercially-available and substantially equivalent Medtronic insertable cardiac monitor
- •Recent HF event within prior 120 days (HF event defined as meeting any one of the following two criteria:
- •Admission with primary diagnosis of HF
- •Intravenous HF therapy (e.g. IV diuretics/vasodilators) or ultrafiltration at any one of the following settings: admission with secondary/tertiary diagnosis of HF, emergency department, ambulance, observation unit, urgent care, HF/cardiology clinic, patient's home
- •Willing and able to transmit data via CareLink
排除标准
- •Patient is pregnant
- •Patient has been participating in another study that may interfere with the IDENTIFY-HF protocol required procedures
- •Endstage (Stage D or New York Heart Association class IV) heart failure
- •Asymptomatic (Stage B or New York Heart Association class I) heart failure
- •Severe aortic stenosis or insufficiency
- •Existing insertable cardiac monitor implanted for more than 1 year
- •Existing implantable pulse generator, implantable cardioverter defibrillator, cardiac resynchronization therapy device
- •Severe renal impairment (estimated glomerular filtration rate <25mL/min)
- •Myocardial infarction within prior 30 days
研究组 & 干预措施
Control arm
Subjects in the Control arm will be observed between implant and month 12. During this time, the standard device diagnostic suite will be used as it would normally, in the office using the programmer, or by data transmission from the patient's home (or another remote location). At month 12 through study close (month 18), study doctors for the all subjects will have access to the risk status.
干预措施: Reveal XT® Insertable Cardiac Monitor (Device)
Control arm
Subjects in the Control arm will be observed between implant and month 12. During this time, the standard device diagnostic suite will be used as it would normally, in the office using the programmer, or by data transmission from the patient's home (or another remote location). At month 12 through study close (month 18), study doctors for the all subjects will have access to the risk status.
干预措施: Heart Failure Risk Status Diagnostic (Other)
Risk Status Guided
Study doctors will have access to the experimental IDENTIFY-HF Risk Status for subjects in the Guided arm between months 6 and 18. At all times during the study, study doctors will also be able to use the standard device diagnostics in the office using the programmer, or by data transmission from the patient's home (or another remote location).
干预措施: Reveal XT® Insertable Cardiac Monitor (Device)
Risk Status Guided
Study doctors will have access to the experimental IDENTIFY-HF Risk Status for subjects in the Guided arm between months 6 and 18. At all times during the study, study doctors will also be able to use the standard device diagnostics in the office using the programmer, or by data transmission from the patient's home (or another remote location).
干预措施: Heart Failure Risk Status Diagnostic (Other)
结局指标
主要结局
Correlation of Heart Failure Risk Score (HFRS) With Heart Failure Events
时间窗: 0 to 6 months post-implant (HFRS Guided Arm), 0-12 months (Control Arm)
Evaluate the HFRS Algorithm prior to Heart Failure (HF) related clinical events among patients with HF and documented or suspected AF. Daily HFRS scores were calculated each day for each patient with an implanted Reveal XT device, and the scores were ordinal, with possible values of "Low", "Medium", "High", and "Very High". The objective was to assess the association between the daily scores before and after HF events (HF-related hospitalizations, clinic visits) among subjects experiencing such visits. This would only be done during follow-up periods in which physicians were blinded to the scores (see Time Frame). The score could only be generated if the subject performed a CareLink transmission of their device data during follow-up. Because of the small number of subjects enrolled, formal statistical analyses were not performed. Subjects were partitioned by whether they (1) experienced a HF event, and (2) whether they experienced a High or Very High HFRS score.
次要结局
未报告次要终点