heaRtInsiGHT Alert guIDE: RightAIDE Application of the HeartInsight Acute Heart Failure Predictor in Routine Clinical Practice: Organizational Models and Workflow.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 12
- 主要终点
- Actionable alerts
研究概览
简要总结
The RightAIDE study is a prospective, multicenter, observational registry designed to evaluate the real-world application of the HeartInsight™ algorithm for predicting acute heart failure (HF) events in patients implanted with a Biotronik ICD or CRT-D device with atrial sensing and Home Monitoring capability. Heart failure is a growing public health issue with high morbidity, mortality, and healthcare costs. HeartInsight, derived and validated in the SELENE HF study, integrates temporal trends of seven physiological variables monitored by the implanted device to provide early warnings of impending acute decompensation, with a median lead time of 42 days. This study aims to collect data on the implementation of a standardized workflow for interpreting and responding to HeartInsight alerts in routine clinical practice. Approximately 100 patients across 14 centers in Italy will be enrolled and followed for 12 months. The primary endpoint is the proportion of HeartInsight alerts considered "actionable," meaning they trigger at least one predefined clinical action (e.g., device reprogramming, therapy optimization, unscheduled visits, or hospital admission). Secondary endpoints include alert frequency, cumulative alert duration, number of patient interviews performed, hospitalizations during and outside alert periods, and the proportion of patients successfully using the HeartInsight Patient App. Data will be collected via electronic case report forms (eCRFs), analyzed descriptively, and monitored for quality. The study will generate insights into integrating HeartInsight-based predictive monitoring into clinical workflows to potentially improve patient management and outcomes.
详细描述
Study Title:
heaRtInsiGHT Alert guIDE: RightAIDE - Application of the HeartInsight acute heart failure predictor in routine clinical practice, organizational models and workflow
Background and Rationale:
Heart failure is a chronic and progressive condition characterized by the inability of the heart to adequately pump blood to meet the body's needs. It is associated with frequent hospitalizations due to episodes of acute decompensation, which substantially contribute to the burden on healthcare systems.
Recent technological advances have enabled the development of predictive algorithms that analyze remotely transmitted data from implanted cardiac devices to forecast clinical events. HeartInsight™ is an integrated algorithm within Biotronik ICDs and CRT-Ds that evaluates trends in seven key physiological parameters: mean and nocturnal heart rate, atrial high-rate episodes, daily physical activity, heart rate variability, ventricular extrasystoles, and thoracic impedance.
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
- •The patient has already received a de novo ICD (DR or DX) or CRT-D within no more than one year, according to guidelines, equipped with atrial sensing and a Home Monitoring system.
- •Documentation of heart failure of ischemic or non-ischemic origin.
- •At the time of device implantation: ejection fraction ≤35% and NYHA Class II or III.
- •Sinus rhythm.
- •Age ≥18 years.
- •The patient has signed the informed consent for participation.
排除标准
- •Patients who have received the implantable device as a replacement or upgrade of a previous one.
- •Patients who have received the device more than one year ago.
- •At the time of enrollment: patient with HeartInsight previously activated.
- •Permanent or long-standing atrial fibrillation.
- •Sinus node disease with indication for atrial pacing.
- •At the time of enrollment: NYHA Class IV.
- •Planned cardiac surgery within three months following enrollment.
- •Life expectancy of less than one year.
- •Unstable residence or insufficient GSM coverage at the patient's home.
- •Pregnancy or breastfeeding.
结局指标
主要结局
Actionable alerts
时间窗: 1 year
Percentage of actionable alerts, defined as alerts that result in one or more predefined clinical actions.
次要结局
- Frequency of HeartInsight Alerts(1 year)
- Cumulative Duration of Alert Periods per Patient(1 year)
- Frequency of Telephone Contacts for Patient Interviews(1 year)
- Frequency of Cardiovascular Hospitalizations(1 year)
- Proportion of Patients Using the HeartInsight Patient App(1 year)