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ACTIVE NOT RECRUITING
NCT07753135

Association of Heart Failure Aggravation and Device-based Sensor Parameters

Sponsor: Samsung Medical Center

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2023-02-01

Completion Date

2027-10-31

Last Updated

2026-08-07

Healthy Volunteers

No

Interventions

DEVICE

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.

Locations (1)

Samsung Medical Center

Seoul, Seoul, South Korea