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.
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.
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.
The study population consists of adult patients with heart failure of ischemic or non-ischemic origin who have been recently implanted with a Biotronik implantable cardioverter defibrillator (ICD) or a cardiac resynchronization therapy defibrillator (CRT-D) with atrial sensing capability and Home Monitoring functionality. Eligible patients must have a left ventricular ejection fraction (LVEF) ≤35% and NYHA functional class II or III at the time of device implantation, be in sinus rhythm, and have provided written informed consent. Patients are excluded if they have received the device as a replacement or upgrade, have had the device implanted for more than one year, have permanent or long-standing atrial fibrillation, require atrial pacing due to sinus node disease, are in NYHA Class IV, are scheduled for cardiac surgery within three months, have a life expectancy of less than one year, have unstable residence or insufficient GSM coverage for Home Monitoring, or are pregnant or breas
Cohort
Prospective
Not listed
Actionable alerts
Percentage of actionable alerts, defined as alerts that result in one or more predefined clinical actions.
Frequency of HeartInsight Alerts
Number of HeartInsight alerts generated for each patient during the 12-month follow-up period.
Cumulative Duration of Alert Periods per Patient
Total cumulative duration, in days, of alert periods per patient during the follow-up, considering periods with the recovery threshold active.
Frequency of Telephone Contacts for Patient Interviews
Number of telephone contacts performed with patients during alert periods, as specified in the predefined workflow.
Frequency of Cardiovascular Hospitalizations
Number of hospitalizations for cardiovascular causes during periods of HeartInsight alert and outside alert periods.
Click on the lead sponsor to view all of their trials.
