NCT03579641

Precision Event Monitoring for Patients With Heart Failure Using HeartLogic

Precision Event Monitoring for Patients With Heart Failure Using HeartLogic: PREEMPT-HF

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,184 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of the PREEMPT-HF study is to collect device and clinical event data to evaluate extended applications of the HeartLogic Heart Failure Diagnostic (HeartLogic) in a broad spectrum of heart failure patients with an implantable cardioverter defibrillator or cardiac resynchronization therapy defibrillator. There are no primary safety and/or efficacy endpoints for this study. Heart failure is a complex clinical syndrome with high morbidity, mortality, and economic burden. Chronic Heart Failure is persistent, gradually progressive, and punctuated by episodes of acute worsening leading to hospitalizations. Therefore, there remains an unmet clinical need to slow the progression of Heart Failure and prevent hospitalizations. HeartLogic, available in Boston Scientific cardiac resynchronization therapy devices and defibrillators, combines novel sensor parameters such as heart sounds and respiration with other measurements like thoracic impedance, heart rate, and activity into a HeartLogic Index for the early detection of worsening Heart Failure. However, there is limited data on the association of HeartLogic with the risk of Hear Failure readmissions and tachyarrhythmias, or for phenotyping the broad spectrum of Heart Failure patients.

Detailed description

Subjects will be followed for approximately 12 months after the baseline visit to collect the required number of clinical events to support the study objectives. These events are called Reviewable Clinical Events, and include all-cause hospitalizations and Heart Failure outpatient visits. Clinical event definitions are as follows: * Hospitalization (all-cause): the subject is admitted to inpatient hospital care and discharged on a different calendar date. * Heart Failure Hospitalization: the subject is admitted with signs/symptoms of congestive heart failure and receives unscheduled augmented Heart Failure therapy with oral or intravenous medications, ultrafiltration therapy or other parenteral therapy. * Heart Failure Readmission (30-day): the subject is admitted for an unplanned hospitalization for any cause within 30 days post discharge from a Heart Failure hospitalization. * Heart Failure Outpatient Visit: the subject has signs/symptoms of Congestive Heart Failure, and receives unscheduled intravenous decongestive therapy (e.g., Intravenous diuretics, Intravenous inotropes, Intravenous vasoactive drugs, ultrafiltration) in a setting that does not involve a hospitalization (e.g., emergency room, Heart Failure clinic, primary care clinic, etc.).

Conditions

• Heart Failure
• Defibrillators, Implantable
• Monitoring, Physiologic
• Cardiac Resynchronization Therapy
• Cardiovascular Disease
• Heart Disease

Interventions

Type	Name	Description
DEVICE	HeartLogic Sensors	HeartLogic Sensors

Timeline

• Start date: 2018-06-01
• Primary completion: 2021-10-29
• Completion: 2021-10-29
• First posted: 2018-07-06
• Last updated: 2022-10-25

Locations

88 sites across 13 countries: United States, Australia, Belgium, Canada, Denmark, France, Germany, Hong Kong, Ireland, Italy, Netherlands, Spain, United Kingdom