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

NCT ID: NCT07281859

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-20
• Study Completion Date: 2027-06-20

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.

Detailed Description

Study Title:

heaRtInsiGHT Alert guIDE: RightAIDE - Application of the HeartInsight acute heart failure predictor in routine clinical practice, organizational models and workflow

Background and Rationale:

Heart failure is a chronic and progressive condition characterized by the inability of the heart to adequately pump blood to meet the body's needs. It is associated with frequent hospitalizations due to episodes of acute decompensation, which substantially contribute to the burden on healthcare systems.

Recent technological advances have enabled the development of predictive algorithms that analyze remotely transmitted data from implanted cardiac devices to forecast clinical events. HeartInsight™ is an integrated algorithm within Biotronik ICDs and CRT-Ds that evaluates trends in seven key physiological parameters: mean and nocturnal heart rate, atrial high-rate episodes, daily physical activity, heart rate variability, ventricular extrasystoles, and thoracic impedance.

HeartInsight, validated in the SELENE HF study, demonstrated the ability to predict 66 percent of heart failure hospitalizations, providing a median lead time of 42 days. Despite this evidence, prospective real-world data on the integration of HeartInsight within routine clinical practice, supported by a structured clinical workflow, are currently lacking.

Study Design:

RightAIDE is a prospective, multicenter, observational registry designed to evaluate the clinical application of HeartInsight in standard practice. Fourteen Italian centers with expertise in remote monitoring of cardiac implantable devices will participate. Additional centers may be added if needed without constituting a protocol amendment.

Approximately 100 patients will be enrolled and followed for 12 months. Enrollment will be non-consecutive to reflect clinical practice. No investigational procedures or additional diagnostic tests will be required. All devices and software used in this study are CE marked and will be used within their approved indications.

Study Objectives:

The primary objective is to quantify the proportion of HeartInsight alerts that lead to a clinical action. Clinical actions include device reprogramming, reinforcement or optimization of prescribed therapy, unscheduled outpatient visits, additional diagnostic testing, or hospitalization linked to the alert period.

Secondary objectives include evaluating the frequency of alerts, the cumulative duration of alert periods per patient, the number of patient interviews during alert periods, hospitalization rates during and outside alert periods, and the proportion of patients able to install and effectively use the HeartInsight Patient App.

Endpoints:

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

Secondary Endpoints: Frequency of alerts per patient, cumulative duration of alert periods, number of telephone interviews conducted in response to alerts, frequency of cardiovascular hospitalizations during and outside alert periods, and rate of Patient App utilization.

Study Procedures:

After verification of eligibility and signing of informed consent, patients will be instructed on the use of the Home Monitoring system, the HeartInsight algorithm, and the optional installation of the Patient App. Patients will be followed for 12 months with remote monitoring and regular clinical visits according to standard care.

When an alert is triggered, the predefined workflow will guide clinical response, including verification of device data, assessment of patient compliance and symptoms, and appropriate interventions as deemed necessary by the treating physician.

Reasons for early withdrawal include interruption of Home Monitoring transmissions for more than 90 days, device removal or replacement, withdrawal of consent, or death.

Sample Size and Statistical Analysis:

Based on prior data from the SELENE HF study indicating an alert rate of approximately 1.1 per patient-year, 91 patients are expected to generate around 100 alerts during the 12-month follow-up. To account for an estimated 10 percent dropout rate, the planned enrollment is 100 patients.

Descriptive statistics will summarize baseline and outcome data. Continuous variables will be reported as quartiles and medians, while categorical variables will be reported as frequencies and percentages. Point estimates and 95 percent confidence intervals will be provided for actionable alert rates and for the incidence of clinical interventions. Statistical analyses will be performed using R software.

Data Management and Confidentiality:

Study data will be collected through electronic case report forms. Personal identifiers will be stored separately from coded study data. Data will be securely stored and retained for up to 15 years in accordance with regulatory requirements.

Ethical Considerations:

The study will be conducted in accordance with the Declaration of Helsinki, Good Clinical Practice (ICH E6 R2), and applicable national regulations. Written informed consent is required prior to participation. Any protocol amendments that could impact patient safety, study endpoints, or key procedures will require ethics committee approval.

Monitoring and Dissemination:

Monitoring will be performed according to a predefined plan to ensure data integrity and protocol compliance. Study results will be disseminated through scientific conferences and peer-reviewed journals. Authorship of publications will be assigned according to predefined performance criteria among participating centers.

Duration:

The enrollment period is planned for approximately 12 months. Each patient will be followed for 12 months, resulting in an overall study duration of approximately 24 months.

Conditions

Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Padova

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dario Gregori, Full Professor

Role: STUDY_CHAIR

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

Gabriele Zanotto, MD

Role: PRINCIPAL_INVESTIGATOR

Dipartimento di Cardiologia, Ospedale Magalini di Villafranca

Locations

Clinica Montevergine

Mercogliano, Avellino, Italy

Site Status: NOT_YET_RECRUITING

Spedali Civili di Brescia

Brescia, Brescia, Italy

Site Status: NOT_YET_RECRUITING

Presidio Ospedaliero di Rho - ASST Rhodense

Rho, Milano, Italy

Site Status: RECRUITING

Ospedale San Gerardo

Monza, Monza, Italy

Site Status: NOT_YET_RECRUITING

Ospedale Monaldi

Napoli, Napoli, Italy

Site Status: NOT_YET_RECRUITING

Ospedale Monaldi

Napoli, Napoli, Italy

Site Status: NOT_YET_RECRUITING

Ospedale Giovanni Paolo II

Ragusa, Ragusa, Italy

Site Status: RECRUITING

Maria Cecilia Hospital

Cotignola, Ravenna, Italy

Site Status: RECRUITING

Ospedale Civile SS. Annunziata

Sassari, Sassari, Italy

Site Status: RECRUITING

Ospedale di Cattinara

Trieste, Trieste, Italy

Site Status: NOT_YET_RECRUITING

Ospedale Mater Salutis di Legnagno

Legnago, Verona, Italy

Site Status: RECRUITING

Ospedale Fracastoro

San Bonifacio, Verona, Italy

Site Status: RECRUITING

Ospedale Magalini di Villafranca

Villafranca di Verona, Verona, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Dario Gregori, Full professor

Role: CONTACT

dario.gregori@ubep.unipd.it

+39 049 8275384

Francesca Angioletti, Registered Nurse

Role: CONTACT

francesca.angioletti@ubep.unipd.it

+39 049 8275384

Facility Contacts

Francesco Solimene

Role: primary

f.solimene@hotmail.com

+39 0825705111

Antonio Curnis

Role: primary

antonio.curnis@libero.it

+39 030 39951

Gianluca Botto

Role: primary

gluca.botto@gmail.com

+39 02 994301

Giovanni Rovaris

Role: primary

rovaris.gi@gmail.com

+39 039 2331

Emilio Di Lorenzo

Role: primary

emilio.dilorenzo@ospedalideicolli.it

+39 081 19725777

Vincenzo Russo

Role: primary

+39 081 19725777

Giuseppe Campisi

Role: primary

giuseppe.campisi@asp.rg.it

+39 0932 600111

Saverio Iacopino

Role: primary

iacopino@iol.it

+39 0545 217111

Giuseppe Sanna

Role: primary

giuseppe.sanna@aouss.it

+39 079 206 1000

Massimo Zecchin

Role: primary

massimo.zecchin@asugi.sanita.fvg.it

+39 040 399 1111

Vincenzo De Simone

Role: primary

vincenzo.desimone@aulss9.veneto.it

+39 0442 622111

Andrea Zorzi

Role: primary

andrea.zorzi@aulss9.veneto.it

+39 045 613 8111

Gabriele Zanotto

Role: primary

gabriele.zanotto@aulss9.veneto.it

+39 045 6338111

Other Identifiers

RightAIDE

Identifier Type: -

Identifier Source: org_study_id