heaRtInsiGHT Alert guIDE: RightAIDE Application of the HeartInsight Acute Heart Failure Predictor in Routine Clinical Practice: Organizational Models and Workflow.
Recruiting · NCT07281859 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Padova
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
13 locations listed.
- Clinica Montevergine - Mercogliano, Avellino, Italy
- Spedali Civili di Brescia - Brescia, Brescia, Italy
- Presidio Ospedaliero di Rho - ASST Rhodense - Rho, Milano, Italy
- Ospedale San Gerardo - Monza, Monza, Italy
- Ospedale Monaldi - Naples, Napoli, Italy
- Ospedale Monaldi - Naples, Napoli, Italy
- Ospedale Giovanni Paolo II - Ragusa, Ragusa, Italy
- Maria Cecilia Hospital - Cotignola, Ravenna, Italy
- Ospedale Civile SS. Annunziata - Sassari, Sassari, Italy
- Ospedale di Cattinara - Trieste, Trieste, Italy
- Ospedale Mater Salutis di Legnagno - Legnago, Verona, Italy
- Ospedale Fracastoro - San Bonifacio, Verona, Italy
- Ospedale Magalini di Villafranca - Villafranca di Verona, Verona, Italy