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Active Not Recruiting NCT07753135

Association of Heart Failure Aggravation and Device-based Sensor Parameters

Conditions: Heart Failure, Cardiomyopathy

Sex: All
Ages: 19 Years – N/A
Healthy volunteers: No
Enrollment: 500
Sponsor: Samsung Medical Center

Location: Samsung Medical Center Seoul Seoul

Summary

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.

Eligibility Criteria

Inclusion Criteria: * Adults aged 19 years or older who provide written informed consent (or consent from a legally authorized representative when applicable) * Diagnosed with heart failure or cardiomyopathy Implanted with a commercially approved Boston Scientific implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) equipped with HeartLogic™, Sleep Incline, and Apnea Scan functions * Enrolled in the LATITUDE™ (NXT 5.0 or later) remote monitoring system and willing to participate in scheduled remote monitoring and follow-up Exclusion Criteria: * Planned heart transplantation or implantation of a ventricular assist device (VAD), or history of VAD implantation within the previous 12 months * Life expectancy of less than 1 year * Inability or unwillingness to comply with the study protocol or follow-up requirements

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07753135). StuddyBuddy aggregates publicly available trial information.