NCT07281859 heaRtInsiGHT Alert guIDE: RightAIDE Application of the HeartInsight Acute Heart Failure Predictor in Routine Clinical Practice: Organizational Models and Workflow.
| NCT ID | NCT07281859 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Padova |
| Condition | Heart Failure |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-06-20 |
| Primary Completion | 2027-06-20 |
Eligibility & Interventions
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-06-20 with a primary completion date of 2027-06-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
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.
Contact & Investigator
Dario Gregori, Full Professor
STUDY CHAIR
Unit of Biostatistics, Epidemiology and Public Health - UBEP, University of Padova
Frequently Asked Questions
Who can join the NCT07281859 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07281859 currently recruiting?
Yes, NCT07281859 is actively recruiting participants. Contact the research team at dario.gregori@ubep.unipd.it for enrollment information.
Where is the NCT07281859 trial being conducted?
This trial is being conducted at Mercogliano, Italy, Brescia, Italy, Rho, Italy, Monza, Italy and 9 additional locations.
Who is sponsoring the NCT07281859 clinical trial?
NCT07281859 is sponsored by University of Padova. The principal investigator is Dario Gregori, Full Professor at Unit of Biostatistics, Epidemiology and Public Health - UBEP, University of Padova. The trial plans to enroll 100 participants.
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