Danish Pragmatic Randomized Trial to Evaluate the Effect of HeartLogic-Guided Management on Heart Failure Outcomes
Recruiting · NCT06099158 · Interventional (participants receive a specific treatment) · Lead sponsor: Tor Biering-Sørensen
View the official record on ClinicalTrials.gov →Interventions studied
HeartLogic
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- There are no specific exclusion criteria for the trial.
Where it is running
1 location listed.
- Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte - Hellerup, Capital Region, Denmark