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HeartLogic Remote Monitoring Trial Heart Failure Apr 22

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Summary

A randomized, multicenter clinical trial has been registered on ClinicalTrials.gov under NCT07544771 to evaluate whether HeartLogic™ algorithm-guided remote management improves outcomes versus traditional face-to-face follow-up in adult heart failure patients recently implanted with a HeartLogic™-enabled ICD or CRT-D device. The primary endpoint at 12 months is a composite of death, unscheduled hospitalization for heart failure, or quality-of-life deterioration. Secondary endpoints include hospitalization, mortality, quality of life, safety, and cost-effectiveness. This is an interventional study with alert-guided remote follow-up as the active intervention and traditional follow-up as the comparator.

“This randomized, multicenter clinical trial will evaluate whether remote management guided by the HeartLogic™ algorithm improves outcomes compared with traditional face-to-face follow-up in adult patients with heart failure recently implanted with a HeartLogic™-enabled ICD or CRT-D device.”

NIH , verbatim from source
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About this source

GovPing monitors ClinicalTrials.gov Studies for new healthcare & life sciences regulatory changes. Every update since tracking began is archived, classified, and available as free RSS or email alerts — 734 changes logged to date.

What changed

A randomized, multicenter clinical trial evaluating HeartLogic™ algorithm-guided remote management against traditional face-to-face follow-up in adult patients with heart failure implanted with HeartLogic™-enabled ICD or CRT-D devices has been registered on ClinicalTrials.gov. The primary objective is to determine whether remote management reduces a composite of death, unscheduled heart-failure hospitalization, or quality-of-life deterioration at 12 months. Secondary objectives include hospitalization, mortality, quality of life, safety, and cost-effectiveness assessments.

Healthcare providers and clinical investigators involved in heart-failure device management may benefit from awareness of this trial's design and endpoints, particularly those assessing whether alert-guided remote follow-up can safely replace or supplement in-office visits for patients with implanted cardiac devices. The trial's cost-effectiveness secondary endpoint may also be of interest to payers and health-system administrators evaluating remote monitoring programs.

Archived snapshot

Apr 23, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

HeartLogic™ in Patients With Heart Failure.

N/A NCT07544771 Kind: NA Apr 22, 2026

Abstract

This randomized, multicenter clinical trial will evaluate whether remote management guided by the HeartLogic™ algorithm improves outcomes compared with traditional face-to-face follow-up in adult patients with heart failure recently implanted with a HeartLogic™-enabled ICD or CRT-D device. The primary objective is to determine whether this strategy reduces, at 12 months, the proportion of patients with death, unscheduled hospitalization for heart failure, or deterioration in quality of life. Secondary objectives include assessment of hospitalization, mortality, quality of life, safety, and cost-effectiveness.

Conditions: Heart Failure

Interventions: Alert-guided remote follow-up, Traditional follow up

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Last updated

Classification

Agency
NIH
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Healthcare providers Clinical investigators Patients
Industry sector
6211 Healthcare Providers 3345 Medical Device Manufacturing
Activity scope
Clinical research Remote patient monitoring
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Compliance frameworks
GxP FDA 21 CFR Part 11
Topics
Medical Devices Clinical Trials

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