heaRtInsiGHT Alert guIDE: RightAIDE Application of the HeartInsight Acute Heart Failure Pr
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 fai
| Condition(s) | Heart Failure |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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 i |
| Who can participate | 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 indicat |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University of Padova |
| Locations | Mercogliano, Avellino, Italy; Brescia, Brescia, Italy; Rho, Milano, Italy; Monza, Monza, Italy; Naples, Napoli, Italy; Naples, Napoli, Italy (+7 more sites) |
| Start date | 2025-06-20 |
| NCT ID | NCT07281859 |
| Official listing | https://clinicaltrials.gov/study/NCT07281859 |