Association of Heart Failure Aggravation and Device-based Sensor Parameters

Cardiomyopathy, Heart Failure

This is a prospective, multicenter, observational patient registry designed to evaluate the association between changes in device-based sensor parameters and heart failure (HF) aggravation in patients implanted with Boston Scientific implantable cardioverter-defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) equipped with HeartLogic™, Sleep Incline, and Apnea Scan functions. The study will prospectively collect remote monitoring and clinical follow-up data to determine whether changes in individual or combined device-based sensor parameters are associated with worsening HF events and to evaluate the clinical utility of remote monitoring for HF management.

Heart failure remains a leading cause of hospitalization and mortality worldwide, and early identification of clinical deterioration is essential for timely intervention. Contemporary cardiac implantable electronic devices (CIEDs) continuously collect physiological information that may provide early indicators of worsening HF. Individual device-derived parameters, including thoracic impedance, heart rate, respiratory rate, physical activity, and heart sounds, have been investigated for HF monitoring; however, the predictive performance of single parameters has been limited by relatively high false-positive rates. HeartLogic™ is a multiparametric algorithm that integrates multiple physiological signals, including heart sounds (S1 and S3), thoracic impedance, respiratory rate, night heart rate, and physical activity, to estimate the risk of impending HF decompensation. Additional device-based diagnostic features, including Sleep Incline and Apnea Scan, may further reflect changes in congestion and respiratory status associated with worsening HF. The combined use of these device-based sensor parameters has the potential to improve risk stratification and facilitate earlier clinical intervention. This prospective, multicenter observational registry will enroll approximately 500 adult patients with HF or cardiomyopathy who have undergone implantation of a commercially approved Boston Scientific ICD or CRT-D equipped with HeartLogic, Sleep Incline, and Apnea Scan functions. Participants will be followed for approximately 15 months using routine in-clinic device evaluations and monthly remote monitoring through the LATITUDE™ system as part of standard clinical care. Clinical events, device-derived physiological parameters, and routine clinical assessments will be prospectively collected. The primary objective is to evaluate the association between changes in device-based sensor parameters and HF worsening events, including HF hospitalization, emergency department visits requiring intensification of HF therapy, or unplanned outpatient visits requiring modification of HF treatment. Secondary objectives include evaluating the association between device-based sensor parameters and recurrent HF hospitalization after discharge, atrial and ventricular arrhythmia events, cardiovascular mortality, stroke or systemic embolism, and assessing the clinical utility and patient satisfaction of remote monitoring using the LATITUDE™ platform.

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