Danish Pragmatic Randomized Trial to Evaluate the Effect of HeartLogic-Guided Management on Heart Failure Outcomes

NCT06099158 · tracked via the Priya Life Science Denmark tracker

Sponsor

Tor Biering-Sørensen

Phase

Not applicable

Started

2024-05-31

Last updated

2025-09-12

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

HeartLogic

HeartLogic: HeartLogic alerts will be managed according to a standardized alert management guide to ensure uniform reactions to HeartLogic alerts.

Study summary

The purpose of the study is to assess the impact of HeartLogic-guided management on clinical outcomes among patients implanted with an eligible cardiac device.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Implanted with a CRT-D or ICD device that has HeartLogic capability and ability to change HeartLogic enablement per randomization 2. Age ≥18 years 3. Compliant with remote monitoring and not listed in the LATITUDE™ remote monitoring system as "not monitored" Exclusion Criteria: There are no specific exclusion criteria for the trial.

Primary outcome measure(s)

Composite endpoint of hospitalization for heart failure or all-cause death (first event) — 42 months

Trial sites (1)

Facility	City	Region	Status
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte	Hellerup	Capital Region	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 NCT06099158 on ClinicalTrials.gov ↗ ← All trials in Denmark