Recruiting

NIRSense

Sponsor:

NIRSense Inc.

Code:

NCT07825363

Conditions

Cardiogenic Shock

Acute Myocardial Infarction

Acute Decompensated Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NIRSense Tissue Oximetry Sensor System

Study Details

Brief summary:

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.

Conditions

Cardiogenic Shock

Acute Myocardial Infarction

Acute Decompensated Heart Failure

Study ID

NCT07825363

Start date

Jun 17, 2025

Status verified date

Sep, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

NIRSense Tissue Oximetry Sensor System

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.

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 and Locations

Central contacts

Thibault Roumengous, PhD

804-625-1135thibault@nirsense.com

Locations

Cleveland Clinic Florida, Weston Hospital

Recruiting

Weston, Florida, United States, 33331

Contacts

David A. Baran, MD

954-659-5290barand@ccf.org

Maxwell Sapper

sapperm2@ccf.org

Principal Investigator:

David A. Baran, MD

More Information

Sponsor

NIRSense Inc.

Last update posted

Sep 17, 2026

Last verified

Sep, 2026

Keywords

  • near-infrared spectroscopy
  • photoplethysmography
  • impedance cardiography
  • tissue oxygen saturation
  • perfusion index
  • microcirculation
  • wearable sensor
  • noninvasive hemodynamic monitoring
  • SCAI shock stage

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by NIRSense Inc. on 2026-09-17.