About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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"
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
HeartLogic
Other interventionHeartLogic alerts will be managed according to a standardized alert management guide to ensure uniform reactions to HeartLogic alerts.
Treatment groups
Trial outcomes
Primary outcomes
Composite endpoint of hospitalization for heart failure or all-cause death (first event)
Secondary outcomes
Composite endpoint of hospitalization for heart failure or all-cause death (recurrent events)
Hospitalization for heart failure (first event)
All-cause hospitalization
All-cause mortality
Other outcomes
Hospitalizations for heart failure (recurrent events)
Hierarchical composite of all-cause mortality, total number of heart failure hospitalizations, and total number of all-cause hospitalizations
All-cause readmission within 30 days after hospitalization for heart failure
Hospitalization for any cardiovascular disease
Sponsors and contacts
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Tor Biering-Sørensen
Lead sponsor
Herlev and Gentofte Hospital
Sponsor institution
Boston Scientific Corporation
Collaborator