heaRtInsiGHT Alert guIDE: RightAIDE Application of the HeartInsight Acute Heart Failure Predictor in Routine Clinical Practice: Organizational Models and Workflow.

Recruiting now

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT07281859

Run by

University of Padova

People needed

100

Starts

2025-06-20

Expected to finish

2027-06-20

Last updated by the study team

2025-12-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

• Ospedale Magalini di Villafranca — Villafranca di Verona, Verona, Italy (enrolling)
• Presidio Ospedaliero di Rho - ASST Rhodense — Rho, Milano, Italy (enrolling)
• Ospedale Giovanni Paolo II — Ragusa, Ragusa, Italy (enrolling)
• Maria Cecilia Hospital — Cotignola, Ravenna, Italy (enrolling)
• Ospedale Civile SS. Annunziata — Sassari, Sassari, Italy (enrolling)
• Ospedale Mater Salutis di Legnagno — Legnago, Verona, Italy (enrolling)
• Ospedale Fracastoro — San Bonifacio, Verona, Italy (enrolling)
• Spedali Civili di Brescia — Brescia, Brescia, Italy
• Ospedale di Cattinara — Trieste, Trieste, Italy
• Ospedale San Gerardo — Monza, Monza, Italy
• Ospedale Monaldi — Naples, Napoli, Italy
• Ospedale Monaldi — Naples, Napoli, Italy
• Clinica Montevergine — Mercogliano, Avellino, Italy

Full record on ClinicalTrials.gov

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