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

NCT07825363 | Recruiting FDA Device

• 2 other identifiers: NSE240125-127
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Correlation between NIRSense sensor measurements and standard-of-care hemodynamic parameters

  Correlation coefficients (Pearson and Spearman) between time-matched NIRSense measurements (tissue oxygen saturation, perfusion index, SpO2, pulse rate, respiratory rate, ICG-derived stroke volume) and standard-of-care clinical measurements (arterial blood pressure, heart rate, pulmonary artery and central venous pressures where a pulmonary artery catheter is present, cardiac output by thermodilution, and lactate).

  Continuous monitoring during the cardiac ICU stay, approximately 24 to 72 hours from sensor application

Secondary Outcomes (4)

• Feasibility: proportion of intended monitoring time with valid sensor data

  Continuous monitoring during the cardiac ICU stay, approximately 24 to 72 hours from sensor application

• Patient tolerance: device-related adverse events and device deficiencies

  From enrollment through sensor removal, approximately 24 to 72 hours

• Association between NIRSense measurement trends and change in SCAI shock stage

  Continuous monitoring during the cardiac ICU stay, approximately 24 to 72 hours from sensor application

• Distribution of NIRSense measurements by SCAI shock stage

  Continuous monitoring during the cardiac ICU stay, approximately 24 to 72 hours from sensor application

Other Outcomes (1)

• Clinical staff usability feedback

  After the device has been used on 5 patients (approximately 1 to 6 months after first enrollment)

Study Arms (2)

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.

Device: NIRSense Tissue Oximetry Sensor System

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.

Device: NIRSense Tissue Oximetry Sensor System

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.

Also known as: Envello Core, NIRSense Sensor Oximetry System patch

Acute decompensated heart failure; Acute myocardial infarction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults admitted to the Cleveland Clinic Florida cardiac intensive care unit with acute myocardial infarction undergoing coronary angiography, or with acutely decompensated heart failure, who are in SCAI shock stage B, C, or D. Participants are recruited from the existing patient population of the recruitment site.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NIRSense Inc.: lead
• Cleveland Clinic Florida: collaborator

Study Sites (1)

Cleveland Clinic Florida, Weston Hospital

Weston, Florida, 33331, United States

RECRUITING

Related Links

• Companion reference-oximetry validation study of the same sensor system

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• David A. Baran, MD

  Cleveland Clinic Florida

  PRINCIPAL INVESTIGATOR

• Thibault Roumengous, PhD

  NIRSense Inc.

  STUDY DIRECTOR

Central Study Contacts

Thibault Roumengous, PhD

CONTACT

804-625-1135; thibault@nirsense.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2026
• First Posted: September 17, 2026
• Study Start: June 17, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 17, 2026

Record last verified: 2026-09

Locations

US (1)