Precision Event Monitoring for Patients With Heart Failure Using HeartLogic (PREEMPT-HF)
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|ClinicalTrials.gov Identifier: NCT03579641|
Recruitment Status : Recruiting
First Posted : July 6, 2018
Last Update Posted : May 12, 2020
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.
|Condition or disease||Intervention/treatment|
|Heart Failure Defibrillators, Implantable Monitoring, Physiologic Cardiac Resynchronization Therapy Cardiovascular Disease Heart Disease||Device: HeartLogic Sensors|
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.).
|Study Type :||Observational|
|Estimated Enrollment :||3750 participants|
|Official Title:||Precision Event Monitoring for Patients With Heart Failure Using HeartLogic: PREEMPT-HF|
|Actual Study Start Date :||June 1, 2018|
|Estimated Primary Completion Date :||November 2024|
|Estimated Study Completion Date :||January 2026|
Implantable Cardiac device with HeartLogic feature
Patients with Heart Failure, implanted with Boston Scientific Implantable Cardioverter Defibrillator or Defibrillator with Cardiac Resynchronization device with HeartLogic feature
Device: HeartLogic Sensors
- Association of HeartLogic sensors with 30-day HF re-admission [ Time Frame: Heartlogic sensor data will be evaluated for the association to HF re-admission during the 30 days after the index event (e.g. the first HF hospitalization that occurs during the trial). ]To compare a mean sensor value change (admission - discharge) between the no-readmission group and the 30-day readmission group.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03579641
|Contact: Karen L Reidt, MBAemail@example.com|
|Contact: Maria Paz Lopez-Chicharro||32-024167201||Maria.Lopez-Chicharro@bsci.com|
|Study Director:||Stephen Gaertner||Boston Scientific Corporation|