Precision Event Monitoring for Patients With Heart Failure Using HeartLogic

Study Overview
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Brief Summary
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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
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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.).

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

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

Intervention / Treatment
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* Device: HeartLogic Sensors


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is age 18 or above, or of legal age to give informed consent specific to each country and national laws. Subject has a documented diagnosis of heart failure. Subject has a Boston Scientific Cardiac Resynchronization Therapy Defibrillator or Implantable Cardioverter Defibrillator device implant that has HeartLogic, with Heart Failure Sensors turned ON, Respiratory Sensor turned ON, and Sleep Incline Sensor turned ON. Subject has an active bipolar right ventricle lead implant. Subject is enrolled in LATITUDE (NXT 5.0 or future version), and is willing to be remotely monitored from the baseline visit for approximately 12 months with HeartLogic disabled. Exclusion Criteria: Subject has received or is scheduled to receive a heart transplant or ventricular assist device (VAD). Subject is enrolled in any concurrent clinical study without prior Boston Scientific written approval (excluding registries). Subject has a life expectancy of less than 12 months. Subject has a history of non-compliance to medical care or known inability to comply with requirements of the clinical study protocol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Implantable Cardiac device with HeartLogic feature<br>Patients with Heart Failure, implanted with Boston Scientific Implantable Cardioverter Defibrillator or Defibrillator with Cardiac Resynchronization device with HeartLogic feature | Device: HeartLogic Sensors<br>* HeartLogic Sensors<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of HeartLogic sensors with 30-day HF re-admission | To compare a mean sensor value change (admission - discharge) between the no-readmission group and the 30-day readmission group. | 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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy Defibrillator, Heart Failure Sensor Data, 30-day Heart Failure Readmission, Ventricular Tachycardia/Ventricular Fibrillation Therapy, Non-Heart Failure Hospitalization, HeartLogic Feature, Latitude Remote Patient Monitor, Data Linkage, Sleep Incline Sensor, Respiratory Sensor, Decongestive Intravenous therapy, Decompensation