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Clinical Trials in South Korea / NCT07753135
Active, not recruiting Observational

Association of Heart Failure Aggravation and Device-based Sensor Parameters

NCT07753135 · tracked via the Priya Life Science South Korea tracker
Sponsor
Samsung Medical Center
Phase
Observational
Started
2023-02-01
Last updated
2026-08-07

Condition(s) studied

Heart FailureCardiomyopathy

Investigational drug(s) / intervention(s)

ICD/CRT-D equipped with HeartLogic, Sleep Incline, and Apnea Scan functions

ICD/CRT-D equipped with HeartLogic, Sleep Incline, and Apnea Scan functions: Commercially approved Boston Scientific implantable cardioverter-defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds) equipped with HeartLogic, Sleep Incline, and Apnea Scan functions. Device-based physiological parameters are collected through routine device interrogation and remote monitoring using the LATITUDE system as part of standard clinical care.

Study 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

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change in Device-Based Sensor Parameters Associated With Heart Failure Worsening Events — From enrollment through the 15-month follow-up period
    To evaluate the association between changes in device-based sensor parameters (including HeartLogic index, heart sounds, thoracic impedance, respiratory rate, night heart rate, physical activity, Sleep Incline, and Apnea Scan) and heart failure worsening events, defined as heart failure hospitalization, emergency department visits requiring intensification of heart failure therapy, or unplanned outpatient visits requiring modification of heart failure treatment.

Trial sites (1)

FacilityCityRegionStatus
Samsung Medical Center Seoul Seoul

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Other trials for the same condition

Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin Recruiting
A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure Recruiting
Personalized Health Coaching for Patients With HF Recruiting
Delayed Initiation of ARNI and SGLT2i in Heart Failure With Corrected Aetiology (DELAY-HF), Pilot Study Recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07753135 on ClinicalTrials.gov ↗ ← All trials in South Korea