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

NCT07281859 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-12-15

No results posted yet for this study

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

Sponsors & Collaborators

  • University of Padova

    lead OTHER

Principal Investigators

  • Dario Gregori, Full Professor · Unit of Biostatistics, Epidemiology and Public Health - UBEP, University of Padova

  • Gabriele Zanotto, MD · Dipartimento di Cardiologia, Ospedale Magalini di Villafranca

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-20
Primary Completion
2027-06-20
Completion
2027-06-20

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07281859 on ClinicalTrials.gov