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