Danish Pragmatic Randomized Trial to Evaluate the Effect of HeartLogic-Guided Management on Heart Failure Outcomes
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Denmark
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
RECRUITING
Hellerup
Contact Information
Primary
Niklas Dyrby Johansen, MD
niklas.dyrby.johansen@regionh.dk
+4520204794
Backup
Marie Terese Barlebo Madsen, PhD
marie.terese.barlebo.madsen@regionh.dk
+4553377345
Time Frame
Start Date: 2024-05-31
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 1428
Treatments
Experimental: HeartLogic-guided management
HeartLogic alerts will be transmitted to the study team, which will subsequently contact the participant to assess any treatment needs. Treatment needs will be assessed according to current clinical practice guidelines.
No_intervention: Standard care
The control group will receive usual HF care in the Danish health system.
Related Therapeutic Areas
Sponsors
Collaborators: Boston Scientific Corporation
Leads: Tor Biering-Sørensen