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.
The study is a pragmatic, registry-based, randomized controlled trial. Eligible patients in Denmark will be randomized 1:1 to either HeartLogic-guided management or usual care. During the trial, patients in the HeartLogic arm will be contacted by the study team in case of any HeartLogic alerts for evaluation and treatment decisions. There will be no mandatory in-person visits scheduled in the trial. HeartLogic alerts will be managed according to a prespecified management guide. Trial data besides device-related data will be retrieved from the Danish nationwide health registries including baseline information and endpoint data. The control group will receive usual HF care in the Danish health system without the involvement of the study team. The study will comply with the standards of the CONSORT statement and the principles of the Declaration of Helsinki.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,428
HeartLogic alerts will be managed according to a standardized alert management guide to ensure uniform reactions to HeartLogic alerts.
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
Hellerup, Capital Region, Denmark
RECRUITINGComposite endpoint of hospitalization for heart failure or all-cause death (first event)
Time frame: 42 months
Composite endpoint of hospitalization for heart failure or all-cause death (recurrent events)
Time frame: 42 months
Hospitalization for heart failure (first event)
Time frame: 42 months
All-cause hospitalization
Time frame: 42 months
All-cause mortality
Time frame: 42 months
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