Status:
RECRUITING
Danish Pragmatic Randomized Trial to Evaluate the Effect of HeartLogic-Guided Management on Heart Failure Outcomes
Lead Sponsor:
Tor Biering-Sørensen
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed Description
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, patie...
Eligibility Criteria
Inclusion
- Implanted with a CRT-D or ICD device that has HeartLogic capability and ability to change HeartLogic enablement per randomization
- Age ≥18 years
- Compliant with remote monitoring and not listed in the LATITUDE™ remote monitoring system as "not monitored"
Exclusion
- There are no specific exclusion criteria for the trial.
Key Trial Info
Start Date :
May 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
1428 Patients enrolled
Trial Details
Trial ID
NCT06099158
Start Date
May 31 2024
End Date
December 1 2027
Last Update
September 12 2025
Active Locations (1)
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1
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
Hellerup, Capital Region, Denmark, 2900