Danish Pragmatic Randomized Trial to Evaluate the Effect of HeartLogic-Guided Management on Heart Failure Outcomes

ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTor Biering-Sørensen

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • HeartLogic

    Other intervention

    HeartLogic alerts will be managed according to a standardized alert management guide to ensure uniform reactions to HeartLogic alerts.

Treatment groups

1,428 Participants
are divided into 2 treatment groups
Group A: HeartLogic-guided managementExperimental treatment 1 intervention
Group B: Standard careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Composite endpoint of hospitalization for heart failure or all-cause death (first event)

Time frame
42 months

Secondary outcomes

1

Composite endpoint of hospitalization for heart failure or all-cause death (recurrent events)

Time frame
42 months
2

Hospitalization for heart failure (first event)

Time frame
42 months
3

All-cause hospitalization

Time frame
42 months
4

All-cause mortality

Time frame
42 months

Other outcomes

1

Hospitalizations for heart failure (recurrent events)

Time frame
42 months
2

Hierarchical composite of all-cause mortality, total number of heart failure hospitalizations, and total number of all-cause hospitalizations

Time frame
42 months
3

All-cause readmission within 30 days after hospitalization for heart failure

Time frame
42 months
4

Hospitalization for any cardiovascular disease

Time frame
42 months

Sponsors and contacts

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Tor Biering-Sørensen

Lead sponsor

Herlev and Gentofte Hospital

Sponsor institution

Boston Scientific Corporation

Collaborator