NCT07825363Recruiting
Clinical Evaluation of NIRSense Tissue Oximetry Sensor Monitoring to Early Detect Cardiogenic Shock
Clinical Evaluation of Using NIRSense Sensor Patch to Measure Microvascular Perfusion Responses and Predict Decompensation in Cardiogenic Shock Patients
Source: ClinicalTrials.gov · Last updated 17 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 20 (estimated)
- First submitted
- 13 Sept 2026
- Start date
- 17 Jun 2025
- Primary completion date
- Jan 2027
- Lead sponsor
- NIRSense Inc.
- Diseases
- Heart failure, Coronary artery disease
- NCT number
- NCT07825363
What you commit to
- Study type: Observational
- Planned participants: 20
- From 17 Jun 2025 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- The investigator believes the participant is not an appropriate candidate for the study
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cleveland Clinic Florida, Weston Hospital Coordinator of this site? Confirm its status | Weston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.