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Precision Event Monitoring for Patients With Heart Failure Using HeartLogic
Recruiting
Trial ID: NCT03579641
Purpose
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.
Official Title
Precision Event Monitoring for Patients With Heart Failure Using HeartLogic: PREEMPT-HF
Eligibility
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
Intervention(s):
device: HeartLogic Sensors
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305