RightAIDE: Using HeartInsight alerts from implanted Biotronik devices to detect early worsening in people with heart failure.

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

This project will test whether using HeartInsight alerts from Biotronik ICD or CRT‑D devices in people with heart failure helps clinics spot and act on early signs of worsening heart failure.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Padova (Academic / other)
• Locations: 13 sites (Mercogliano, Avellino and 12 other locations)
• Trial ID: NCT07281859 on ClinicalTrials.gov

What this trial studies

RightAIDE is a prospective, multicenter observational registry enrolling about 100 patients with Biotronik ICD or CRT‑D devices and Home Monitoring to document real‑world implementation of the HeartInsight acute heart failure predictor. The algorithm integrates trends from seven device‑measured physiologic variables and has a reported median lead time of 42 days for impending decompensation. Participating centers will follow patients for 12 months using a standardized workflow to interpret and respond to HeartInsight alerts. The primary endpoint is the proportion of HeartInsight alerts judged by clinicians to require a clinical response.

Who should consider this trial

Good fit: Adults (≥18 years) with a de novo Biotronik ICD (DR or DX) or CRT‑D implanted within the past year, atrial sensing and Home Monitoring enabled, documented ischemic or non‑ischemic heart failure, left ventricular ejection fraction ≤35% and NYHA class II–III in sinus rhythm are the intended participants.

Not a fit: Patients without a compatible Biotronik device or Home Monitoring, those with permanent or long‑standing atrial fibrillation, NYHA class IV, planned near‑term cardiac surgery, life expectancy <1 year, or devices implanted >1 year are unlikely to gain from this protocol.

Why it matters

Potential benefit: If successful, using HeartInsight alerts in routine care could give clinicians earlier warnings of worsening heart failure, enabling timelier interventions that may reduce hospitalizations.

How similar studies have performed: HeartInsight was derived and validated in the SELENE‑HF study, which reported prediction of about 66% of heart failure hospitalizations with a median lead time of 42 days.

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.

Where this trial is running

Mercogliano, Avellino and 12 other locations

• 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)
• Ospedale Magalini di Villafranca — Villafranca di Verona, Verona, Italy (Recruiting)

Study contacts

• Principal investigator: Gabriele Zanotto, MD — Dipartimento di Cardiologia, Ospedale Magalini di Villafranca
• Study coordinator: Dario Gregori, Full professor

Conditions Heart Failure; Remote Cardiac Monitoring