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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Presidio Ospedaliero di Rho - ASST Rhodense
  Rho, Milano, Italy 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 Mater Salutis di Legnagno
  Legnago, Verona, Italy Recruiting
• Ospedale Fracastoro
  San Bonifacio, Verona, Italy Recruiting

Study contacts

• Principal investigator: Gabriele Zanotto, MD — Dipartimento di Cardiologia, Ospedale Magalini di Villafranca
• Study coordinator: Dario Gregori, Full professor
• Email: dario.gregori@ubep.unipd.it
• Phone: +39 049 8275384

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.