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

NCT07281859 | Recruiting

• 1 other identifier: RightAIDE
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 13

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.

Conditions

Heart Failure

Keywords

Heart Failure; Remote Cardiac Monitoring

Outcome Measures

Primary Outcomes (1)

• Actionable alerts

  Percentage of actionable alerts, defined as alerts that result in one or more predefined clinical actions.

  1 year

Secondary Outcomes (5)

• Frequency of HeartInsight Alerts

  1 year

• Cumulative Duration of Alert Periods per Patient

  1 year

• Frequency of Telephone Contacts for Patient Interviews

  1 year

• Frequency of Cardiovascular Hospitalizations

  1 year

• Proportion of Patients Using the HeartInsight Patient App

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients with heart failure of ischemic or non-ischemic origin who have been recently implanted with a Biotronik implantable cardioverter defibrillator (ICD) or a cardiac resynchronization therapy defibrillator (CRT-D) with atrial sensing capability and Home Monitoring functionality. Eligible patients must have a left ventricular ejection fraction (LVEF) ≤35% and NYHA functional class II or III at the time of device implantation, be in sinus rhythm, and have provided written informed consent. Patients are excluded if they have received the device as a replacement or upgrade, have had the device implanted for more than one year, have permanent or long-standing atrial fibrillation, require atrial pacing due to sinus node disease, are in NYHA Class IV, are scheduled for cardiac surgery within three months, have a life expectancy of less than one year, have unstable residence or insufficient GSM coverage for Home Monitoring, or are pregnant or breas

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.

Sponsors & Collaborators

• University of Padova: lead

Study Sites (13)

Clinica Montevergine

Mercogliano, Avellino, 83013, Italy

NOT YET RECRUITING

Spedali Civili di Brescia

Brescia, Brescia, 25123, Italy

NOT YET RECRUITING

Presidio Ospedaliero di Rho - ASST Rhodense

Rho, Milano, 20017, Italy

RECRUITING

Ospedale San Gerardo

Monza, Monza, 20900, Italy

NOT YET RECRUITING

Ospedale Monaldi

Naples, Napoli, 80131, Italy

NOT YET RECRUITING

Ospedale Monaldi

Naples, Napoli, 80131, Italy

NOT YET RECRUITING

Ospedale Giovanni Paolo II

Ragusa, Ragusa, 97100, Italy

RECRUITING

Maria Cecilia Hospital

Cotignola, Ravenna, 48033, Italy

RECRUITING

Ospedale Civile SS. Annunziata

Sassari, Sassari, 07100, Italy

RECRUITING

Ospedale di Cattinara

Trieste, Trieste, 34149, Italy

NOT YET RECRUITING

Ospedale Mater Salutis di Legnagno

Legnago, Verona, 37045, Italy

RECRUITING

Ospedale Fracastoro

San Bonifacio, Verona, 37047, Italy

RECRUITING

Ospedale Magalini di Villafranca

Villafranca di Verona, Verona, 37069, Italy

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Dario Gregori, Full Professor

  Unit of Biostatistics, Epidemiology and Public Health - UBEP, University of Padova

  STUDY CHAIR

• Gabriele Zanotto, MD

  Dipartimento di Cardiologia, Ospedale Magalini di Villafranca

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dario Gregori, Full professor

CONTACT

+39 049 8275384; dario.gregori@ubep.unipd.it

Francesca Angioletti, Registered Nurse

CONTACT

+39 049 8275384; francesca.angioletti@ubep.unipd.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 15, 2025
• Study Start: June 20, 2025
• Primary Completion (Estimated): June 20, 2027
• Study Completion (Estimated): June 20, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-09

Locations

IT (13)