Condition: Heart Failure · Sponsor: University of Padova
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 descriptivel…
This description comes directly from the study's public registry record.
Dario Gregori, Full professor · +39 049 8275384 · dario.gregori@ubep.unipd.it
Francesca Angioletti, Registered Nurse · +39 049 8275384 · francesca.angioletti@ubep.unipd.it
Always discuss trial participation with your own doctor first.
| Clinica Montevergine | Mercogliano, Avellino, Italy | Not Yet Recruiting |
| Spedali Civili di Brescia | Brescia, Brescia, Italy | Not Yet Recruiting |
| Presidio Ospedaliero di Rho - ASST Rhodense | Rho, Milano, Italy | Recruiting |
| Ospedale San Gerardo | Monza, Monza, Italy | Not Yet Recruiting |
| Ospedale Monaldi | Naples, Napoli, Italy | Not Yet Recruiting |
| Ospedale Monaldi | Naples, Napoli, Italy | Not Yet Recruiting |
| Ospedale Giovanni Paolo II | Ragusa, Ragusa, Italy | Recruiting |
| Maria Cecilia Hospital | Cotignola, Ravenna, Italy | Recruiting |
| Ospedale Civile SS. Annunziata | Sassari, Sassari, Italy | Recruiting |
| Ospedale di Cattinara | Trieste, Trieste, Italy | Not Yet Recruiting |
| Ospedale Mater Salutis di Legnagno | Legnago, Verona, Italy | Recruiting |
| Ospedale Fracastoro | San Bonifacio, Verona, Italy | Recruiting |
+ 1 more locations — full list on the registry record.
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT07281859