Association of Heart Failure Aggravation and Device-based Sensor Parameters

NCT07753135 | Active Not Recruiting

• 2 other identifiers: SMC-2022-06-119ISRRM12367
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure; Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Change in Device-Based Sensor Parameters Associated With Heart Failure Worsening Events

  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.

  From enrollment through the 15-month follow-up period

Secondary Outcomes (5)

• Heart Failure Rehospitalization After Index Heart Failure Hospitalization

  Up to 3 months after discharge

• Cardiac Arrhythmia Events

  From enrollment through the 15-month follow-up period

• Cardiovascular Mortality

  From enrollment through the 15-month follow-up period

• Stroke or Systemic Embolism

  From enrollment through the 15-month follow-up period

• Clinical Utility of Remote Monitoring

  At the end of the 15-month follow-up

Study Arms (1)

Heart Failure or Cardiomyopathy Patients with ICD/CRT-D

Adult patients with heart failure or cardiomyopathy implanted with a commercially approved Boston Scientific ICD or CRT-D equipped with HeartLogic, Sleep Incline, and Apnea Scan functions who are enrolled in this prospective observational registry.

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

Interventions

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

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.

Heart Failure or Cardiomyopathy Patients with ICD/CRT-D

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with heart failure or cardiomyopathy implanted with HeartLogic-enabled Boston Scientific ICD or CRT-D devices who are enrolled in the LATITUDE remote monitoring system. Participants are prospectively followed to evaluate the relationship between device-based sensor parameters and clinical heart failure outcomes.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Heart Failure; Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 7, 2026
• Study Start: February 1, 2023
• Primary Completion (Estimated): August 8, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: August 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)