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Clinical Trial Summary

The goal of the PREEMPT-HF study is to collect device and clinical event data to evaluate extended applications of the HeartLogicTM Heart Failure Diagnostic (HeartLogic) in a broad spectrum of heart failure (HF) patients with an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D). There are no primary safety and/or efficacy endpoints for this study.

Heart failure (HF) is a complex clinical syndrome with high morbidity, mortality, and economic burden. Chronic HF 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 HF and prevent hospitalizations. HeartLogicTM, available in Boston Scientific cardiac resynchronization therapy devices and defibrillators (CRT-Ds and ICDs), 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 HF. However, there is limited data on the association of HeartLogic with the risk of HF readmissions and tachyarrhythmias, or for phenotyping the broad spectrum of HF patients.

Clinical Trial 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 (RCEs), and include all-cause hospitalizations and HF 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.

- HF Hospitalization: the subject is admitted with signs/symptoms of congestive heart failure (CHF) and receives unscheduled augmented HF therapy with oral or intravenous medications, ultrafiltration therapy or other parenteral therapy.

- HF Readmission (30-day): the subject is admitted for an unplanned hospitalization for any cause within 30 days post discharge from a HF hospitalization.

- HF Outpatient Visit: the subject has signs/symptoms of CHF, and receives unscheduled intravenous decongestive therapy (e.g., IV diuretics, IV inotropes, IV vasoactive drugs, ultrafiltration) in a setting that does not involve a hospitalization (e.g., emergency room, HF clinic, primary care clinic, etc.). ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03579641
Study type Observational
Source Boston Scientific Corporation
Contact Karen L Reidt, MBA
Phone 651-202-8033
Status Recruiting
Start date June 1, 2018
Completion date January 2026

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