Clinical trials: Hemodynamic Monitoring
Heart Failure
Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure (COMPASS-HF)
COMPASS-HF was a prospective, two-arm, randomized (1:1), multi-center, parallel controlled study. The purpose of the randomized study was to test the safety of an implantable hemodynamic monitor (IHM) and pressure sensor lead.
- Trial name
- NCT00643279
- Testing
- Chronicle Implantable Hemodynamic Monitor, Standard of Care
- Where
- 28 sites in United States
- Volunteers
- 277 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Blood Loss, Surgical, Postoperative Hemorrhage
Study of the Hemorai Vysio Wearable Device for Monitoring Changes Related to Blood Loss in Patients During and After Surgery.
The goal of this clinical trial is to learn whether the Hemorai Vysio wearable device can be used safely and feasibly to track relative changes over time in tissue oxygen, hemoglobin-related signals, blood flow, and oxygen use…
- Trial name
- VYSIO-FEASIBIL (NCT07826637)
- Testing
- Wearable optical hemodynamic monitoring device
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Hemorai Inc
Hemodynamic Monitoring
The EU Hyprotect Registry
European, multicenter, prospective, observational registry in patients undergoing elective major non-cardiac surgery
- Trial name
- NCT04972266
- Testing
- AcumenTM Hypotension Prediction Index software
- Where
- 12 sites in France, Germany and 3 more
- Volunteers
- 702 people
- Sponsor
- Edwards Lifesciences
Hemodynamic Monitoring
Evaluation of the UltraTrac System as a Non-Invasive Monitor of Hemodynamic Parameters
This study will test the use of the UltraTrac™ system, a small, noninvasive device that uses electrodes on the skin and a small ultrasound sensor to provide measurements of cardiac function in a wide of subjects.
- Trial name
- NCT07862608
- Testing
- Noninvasive Hemodynamic Monitoring System
- Where
- United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- AcQumen Medical, Inc.
Heart Failure, Heart Failure Hospitalization
Non-Invasive Hemodynamic Monitoring in Hospitalized Heart Failure
Heart failure hospitalization is associated with a high risk of early readmission and mortality. There is an unmet clinical need for low-burden, non-invasive methods to better understand congestion and hemodynamic status during…
- Conditions
- Heart Failure, Heart Failure Hospitalization, Heart Failure (HF)
- Trial name
- NCT07671742
- Where
- Sweden
- Volunteers
- 1,000 people
- Sponsor
- Acorai AB
Hemodynamic Monitoring
Starling/CRRT Observational Study
Hemodynamic optimization of critically ill patients is a goal for clinicians in order to afford the patient the best possible outcomes.
- Trial name
- NCT05729048
- Testing
- Starling
- Where
- United States
- Sponsor
- Baxter Healthcare Corporation
Congestive Heart Failure
Relation of Non-invasively Measured Parameters to Clinical Outcomes in CHF Patients
Our aim is to assess whether changes in CO, CI and SVR as measured using the Biobeat wearable, wireless, non-invasive device during IV diuretic administration in an outpatient setting among CHF patients correlate with short-term…
- Trial name
- NCT04548024
- Testing
- Short term monitoring
- Where
- Israel
- Volunteers
- 50 people
- Sponsor
- Biobeat Technologies Ltd.
Critically Ill, Hemodynamic Instability
Comparing the PiCCO Monitor to the Non-invasive Biobeat (BB)-316PW in ICU Patients
The aim of this study is to compare hemodynamic monitoring using the invasive PiCCO device to the BB-613PW wireless, non-invasive PPG-based device, in critically ill patients within the ICU, suffering from hemodynamic instability…
- Trial name
- NCT04215627
- Testing
- non-invasive monitoring
- Where
- Israel
- Volunteers
- 9 people
- Sponsor
- Biobeat Technologies Ltd.
Mechanical Ventilation, Ventilation Perfusion Mismatch
Post-hoc Analysis of Regional Pulmonary Perfusion and Hemodynamic Parameters Measured by Electrical Impedance Tomography
Define the capability and reliability of the PulmoVista® 500 (PV500) to detect changes in global and regional ventilation and perfusion.
- Trial name
- NCT04249414
- Testing
- PulmoVista 500
- Where
- Germany
- Volunteers
- 22 people
- Sponsor
- Drägerwerk AG & Co. KGaA
Sepsis
CLEAR Sepsis Clinical Study
To investigate the relationship between initial ClearSight™ derived hemodynamic parameters and outcomes (death, ongoing organ dysfunction or delayed ICU admission) in patients with acute infection and possible sepsis, with a…
- Trial name
- CLEAR Sepsis (NCT03231956)
- Testing
- ClearSight™ / EV1000NI Clinical Platform
- Where
- 5 sites in United States
- Volunteers
- 182 people
- Sponsor
- Edwards Lifesciences
Hemodynamic Monitoring
Starling Registry Study
Hemodynamic optimization of critically ill patients is a goal for clinicians in order to afford the patient the best possible outcomes.
- Trial name
- NCT04648293
- Testing
- Starling
- Where
- 9 sites in United States
- Volunteers
- 1,207 people
- Sponsor
- Baxter Healthcare Corporation
Heart Failure
Acorai Machine Learning Generalization (MLG) Study
Acorai is developing a non-invasive monitoring system for the estimation of intracardiac hemodynamic parameters in patients with suspected or confirmed heart failure, and/or pulmonary hypertension, who require hemodynamic…
- Trial name
- CAPTURE-HF (NCT05835024)
- Testing
- Acorai Sensor Data Collection (ASDC) system 1.0 - Phase 1, Acorai Sensor Data Collection (ASDC) system 1.0 - Phase 2
- Where
- 18 sites in United States, Belgium and 4 more
- Volunteers
- 1,602 people, healthy volunteers welcome
- Sponsor
- Acorai AB
Heart Failure
Monitoring of Hemodynamics in Heart Failure Patients by Intracardiac Impedance Measurement
Heart Failure (HF) is one of the most frequent diagnoses upon hospitalization and is a major cause of death. Cardiac resynchronization therapy (CRT) using an implantable device for synchronous bi-ventricular stimulation leads to…
- Trial name
- BIODetectHFII (NCT01711281)
- Testing
- Intracardiac Impedance Measurement Algorithm (integrated in CRT-D device)
- Where
- 22 sites in Denmark, Germany and 3 more
- Volunteers
- 68 people
- Sponsor
- Biotronik SE & Co. KG
Heart Failure, Heart Diseases
Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure
The purpose of TEAM-HF IDE clinical trial is to evaluate safety and effectiveness of the HeartMate 3 LVAS compared to guideline directed medical therapy (GDMT) in a population of ambulatory advanced heart failure patients who are…
- Conditions
- Heart Failure, Heart Diseases, Cardiovascular Diseases, Pulmonary Hypertension
- Trial name
- TEAM-HF (NCT06526195)
- Testing
- CardioMEMS HF System, HeartMate 3 Left Ventricular Assist System, Guideline Medical Directed Therapy
- Where
- 68 sites in United States, Austria and 6 more
- Volunteers
- 850 people
- Sponsor
- Abbott Medical Devices
Hemodynamic Monitoring
UltraTrac Clinical Pilot Study
This single-center pilot study will evaluate the accuracy and feasibility of non-invasive cardiac output measurement using the UltraTrac device in pediatric patients aged 0-21 years undergoing standard-of-care diagnostic cardiac…
- Trial name
- ULTRA-CO (NCT07864714)
- Testing
- Noninvasive Hemodynamic Monitoring System
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- AcQumen Medical, Inc.
Pediatric ALL
Pediatric Cardiac Output Monitoring Observational Study
To assess Cardiac Output Monitoring in pediatric subjects by comparing FloTrac and ClearSight system to intermittent thermodilution Swan-Ganz, in order to expand the indications of FloTrac, ClearSight and Swan-Ganz thermodilution…
- Trial name
- POGO (NCT04465370)
- Testing
- Hemosphere Advanced Monitoring System, ClearSight 1.5, Swan-Ganz Catheter, Flotrac, Foresight
- Where
- 3 sites in United States
- Volunteers
- 89 people
- Sponsor
- Edwards Lifesciences
Peripheral Artery Disease
Monitoring Local Tissue Oxygen Changes Using the Wireless Lumee Oxygen Platform in Correlation to TcPO2
The purpose of this study is to monitor changes in local tissue oxygen levels in participants with Peripheral Artery Disease (PAD) using the Wireless Lumee Oxygen Platform.
- Trial name
- NCT04514861
- Testing
- Wireless Lumee Oxygen Platform
- Where
- 3 sites in United States
- Volunteers
- 53 people
- Sponsor
- Profusa, Inc.
Heart Failure, Dyspnea
Correlation Research Study: IQ2, NcIQ and IQ101
The new NcIQ thoracic impedance monitor is based on the predicate device, the IQ101. The new model uses the same 3-dimensional signal averaging as the original device, but also include second radio frequency signal to permit the…
- Conditions
- Heart Failure, Dyspnea, Hypertension, Pacemaker
- Trial name
- NMT-CT (NCT00491777)
- Testing
- Noninvasive Hemodynamic Patient Monitor
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Noninvasive Medical Technologies, Inc.
Carotid Stenosis
A First-in-Human Feasibility Study of the Vibrant Stroke Detection Technology During Carotid Endarterectomies
The goal of this observational study is to learn whether continuous carotid artery blood flow signals can be recorded reliably during surgery, and whether Vibrant Medical's analysis method can detect measurable changes in those…
- Trial name
- NCT07851389
- Testing
- Bilateral carotid Doppler signal acquisition (Vibrant Stroke Detection Technology)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Vibrant Medical Ltd.
Sepsis, Abdominal Sepsis
Personalised Real-time Interoperable Sepsis Monitoring (PRISM)
The goal of this prospective observational study is to develop and utilize an Artificial Intelligence (AI) model for the prediction of postoperative sepsis in patients undergoing abdominal surgery.
- Conditions
- Sepsis, Abdominal Sepsis, Infections, Clinical Deterioration
- Trial name
- PRISM (NCT06238180)
- Testing
- PRISM Tool
- Where
- Greece
- Sponsor
- Aisthesis Medical P.C.