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

Part of paid clinical trials in Weston, Florida.

Sponsor
NIRSense Inc.
Study ID
NCT07825363
Status
Recruiting
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Conditions

  • Acute Decompensated Heart Failure
  • Acute Myocardial Infarction
  • Cardiogenic Shock

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NIRSense Tissue Oximetry Sensor System — DEVICE
    Investigational noninvasive wearable sensor patches using near-infrared spectroscopy and photoplethysmography to continuously measure tissue oxygen saturation, SpO2, pulse rate, respiratory rate, and perfusion index, plus an ECG/ICG sensor patch for stroke volume, with a tablet display and recording application. Sensors are applied to the sternum, forearm, and other locations with a medical-grade adhesive and worn for approximately 24 to 72 hours during standard cardiac ICU care. Sensor data are collected for research only and are not used for treatment decisions.

Study Details

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 standard-of-care hemodynamic and laboratory measurements and with the patient's clinical course to evaluate the feasibility of the device, the correlation of its measurements with established clinical parameters, and its potential to detect deterioration in SCAI shock stage earlier. No treatment decisions are made based on the study device.

Key Dates

First listed
Sep 17, 2026
Start date
Jun 17, 2025
Status verified
Sep 2026
Primary completion
Jan 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: Acute myocardial infarction
    Patients with acute myocardial infarction, with or without shock (SCAI stage B to D), admitted for coronary angiography and subsequent interventions. Enrolled at the time of consent for coronary angiography.
  • Arm: Acute decompensated heart failure
    Patients with acute decompensated heart failure (SCAI stage B to D) admitted for pulmonary artery catheter insertion and subsequent interventions. Consented before or after catheterization.

Primary Outcome Measure

Correlation between NIRSense sensor measurements and standard-of-care hemodynamic parameters [ Time Frame: Continuous monitoring during the cardiac ICU stay, approximately 24 to 72 hours from sensor application ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic Florida, Weston HospitalWestonFlorida33331
David A. Baran, MD
[email protected]
954-659-5290
Maxwell Sapper
[email protected]
David A. Baran, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Cleveland Clinic Florida, Weston Hospital· Weston, FL

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