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Clinical Evaluation of NIRSense Tissue Oximetry Sensor Monitoring to Early Detect Cardiogenic Shock

Recruitingn/aAges 18 Years - anyAllNIRSense Inc.
NCT07825363 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a prospective, single-center, observational pilot study of the investigational NIRSense Tissue Oximetry Sensor System (Envello Core), a noninvasive wearable sensor patch that uses near-infrared spectroscopy (NIRS) and photoplethysmography (PPG), combined with an electrocardiography/impedance cardiography (ECG/ICG) sensor, to continuously monitor tissue oxygen saturation (StO2), peripheral oxygen saturation (SpO2), pulse rate, respiratory rate, stroke volume, and related metrics. Up to 20 adults admitted to the Cleveland Clinic Florida cardiac intensive care unit with acute myocardial infarction or acute decompensated heart failure and in Society for Cardiovascular Angiography and Interventions (SCAI) shock stage B, C, or D will wear the sensors on the sternum, forearm, and other locations for approximately 24 to 72 hours during standard care. Sensor data will be compared with sta

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📋 Eligibility rules (as published)
Inclusion Criteria: * Acutely decompensated symptomatic heart failure (HF) documented by: (a) symptoms of HF requiring current treatment; (b) Society for Cardiovascular Angiography and Interventions (SCAI) stage B, C, or D; and (c) hospital admission with HF as the primary or secondary diagnosis; OR acute myocardial infarction (MI) patient undergoing coronary angiography * Admitted to the intensive care unit and currently in SCAI stage B, C, or D * Age 18 years or older * Weight greater than 40 kg Exclusion Criteria: * Prior known severe allergy to medical-grade adhesive or tape (self-reported) * Currently participating in an investigational drug or device study that would interfere with the conduct or results of this study. Trials requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational. * The investigator believes the participant is not an appropriate candidate for the study
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What it tests

  • NIRSense Tissue Oximetry Sensor System
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Where

1 site
Cleveland Clinic Florida, Weston Hospital
Weston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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