Hemodynamic InstabilityNCT07148323
HemoSphere Alta Study
An observational study of Hemodynamic Instability, run by Becton, Dickinson and Company at 1 site in United States.
Trial summary
A prospective, non-randomized single arm study using the HemoSphere Alta Advanced Monitoring Platform and associated devices in adult subjects. Data collected from enrolled study subjects will be used for continual device development purposes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamic Instability
- What is being tested?
- HemoSphere Alta Monitor, Swan-Ganz IQ pulmonary arterial catheter, ForeSight IQ Large sensor, and Acumen IQ sensor
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Up to 100 subjects with planned monitoring with a pulmonary artery catheter in the Operating Room (OR). Subjects must meet the eligibility criteria for the Primary Cohort to be enrolled in the study. Subjects may further qualify for inclusion in Sub-Cohorts A and/or B. Sub-Cohort A Right Ventricular Failure (RVF) will include up to 25 subjects undergoing either non-cardiac or cardiac surgery with a planned transesophageal echocardiogram (TEE) assessment. Sub-Cohort B Cerebral Autoregulation Index (CAI) will include up to 50 subjects aged ≥ 45 years undergoing Cardiopulmonary Bypass (CPB) with the ability to place ForeSight and Acumen IQ sensors and are at high risk for cerebrovascular disease.
Who may be able to join
- Signed informed consent
- Age ≥ 18 years
- Planned monitoring with a pulmonary artery catheter
- Patient scheduled to undergo cardiac or liver transplant surgery lasting > 2 hours
- Additional criteria for Sub-Cohort A (RVF)
- Possible Right Ventricular Dysfunction/Failure based on pre-operative assessment of previous Transthoracic Echocardiogram (TTE)
Show all 12Show fewer
- Planned Transesophageal Echocardiogram (TEE) assessment during the operative procedure
- Additional criteria for Sub-Cohort B (CAI)
- Age ≥ 45 years
- Planned cardiac surgery with Cardiopulmonary Bypass (CPB)
- Ability to place ForeSight IQ and Acumen IQ sensors during the operative monitoring period
- High risk for cerebral vascular disease, defined as: a history of hypertension, pulse pressure > 60 mmHg, diabetes, stroke, transient ischemic attack, carotid bruit, tobacco smoking, or peripheral vascular disease
Who cannot join
- Inability to provide informed consent
- Pregnancy as confirmed per EMR
- Patients deemed not suitable for the study at the discretion of the Investigator
- Participation in another study that clinically interferes with the current study
- Additional exclusion criteria for Sub-Cohort A
- Presence of left bundle branch block
Show all 10Show fewer
- Presence of current/recurrent sepsis
- Presence of hypercoagulability, as identified in the patient's past medical history and preoperative evaluation
- Structural abnormality, including congenital heart defects, of the right ventricle
- Additional exclusion criteria for Sub-Cohort B a. Surgery for congenital heart defect
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14620
About this study
Official title: HemoSphere Alta Clinical Development Study
A prospective, non-randomized single arm study using the HemoSphere Alta Advanced Monitoring Platform and associated devices in adult subjects. Data collected from enrolled study subjects will be used for continual device development purposes.
- Conditions
- Hemodynamic Instability
- Being tested
- HemoSphere Alta Monitor, Swan-Ganz IQ pulmonary arterial catheter, ForeSight IQ Large sensor, and Acumen IQ sensor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemoSphere Alta Monitor, Swan-Ganz IQ pulmonary arterial catheter, ForeSight IQ Large sensor, and Acumen IQ sensorDevice
Subjects with planned monitoring with a pulmonary artery catheter in the operating room, will be monitored with the above listed devices.
| Study group | Role | What they receive |
|---|---|---|
| Primary Cohort (Swan) | Up to 100 subjects with planned monitoring with a pulmonary artery catheter in the OR. Receives: Device: HemoSphere Alta Monitor, Swan-Ganz IQ pulmonary arterial catheter, ForeSight IQ Large sensor, and Acumen IQ sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data Collection using HemoSphere Alta Advanced Monitoring Platform and associated devices
Number of patients who receive monitoring using the HemoSphere Alta Advanced Monitoring Platform and associated devices for continued device development.
Measured: Up to 72 hours of device data collection during surgery and ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start14 Oct 2025
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148323
- Sponsor's protocol ID
- 2025-05
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HemoSphere Alta Clinical Development Study
- ClinicalTrials.gov ID
- NCT07148323
- Acronym / sponsor ID
- 2025-05
- Conditions
- Hemodynamic Instability
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, non-randomized single arm study using the HemoSphere Alta Advanced Monitoring Platform and associated devices in adult subjects. Data collected from enrolled study subjects will be used for continual device development purposes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Cohort (Swan) | – | Device: HemoSphere Alta Monitor, Swan-Ganz IQ pulmonary arterial catheter, ForeSight IQ Large sensor, and Acumen IQ sensorUp to 100 subjects with planned monitoring with a pulmonary artery catheter in the OR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 100 subjects with planned monitoring with a pulmonary artery catheter in the Operating Room (OR). Subjects must meet the eligibility criteria for the Primary Cohort to be enrolled in the study. Subjects may further qualify for inclusion in Sub-Cohorts A and/or B. Sub-Cohort A Right Ventricular Failure (RVF) will include up to 25 subjects undergoing either non-cardiac or cardiac surgery with a planned transesophageal echocardiogram (TEE) assessment. Sub-Cohort B Cerebral Autoregulation Index (CAI) will include up to 50 subjects aged ≥ 45 years undergoing Cardiopulmonary Bypass (CPB) with the ability to place ForeSight and Acumen IQ sensors and are at high risk for cerebrovascular disease.
Key inclusion criteria (12 listed)
- Signed informed consent
- Age ≥ 18 years
- Planned monitoring with a pulmonary artery catheter
- Patient scheduled to undergo cardiac or liver transplant surgery lasting > 2 hours
- Additional criteria for Sub-Cohort A (RVF)
Key exclusion criteria (10 listed)
- Inability to provide informed consent
- Pregnancy as confirmed per EMR
- Patients deemed not suitable for the study at the discretion of the Investigator
- Participation in another study that clinically interferes with the current study
- Additional exclusion criteria for Sub-Cohort A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemoSphere Alta Monitor, Swan-Ganz IQ pulmonary arterial catheter, ForeSight IQ Large sensor, and Acumen IQ sensorSubjects with planned monitoring with a pulmonary artery catheter in the operating room, will be monitored with the above listed devices. | Device | Primary Cohort (Swan) |
Primary outcome
Data Collection using HemoSphere Alta Advanced Monitoring Platform and associated devices
Time frame: Up to 72 hours of device data collection during surgery and ICU
Number of patients who receive monitoring using the HemoSphere Alta Advanced Monitoring Platform and associated devices for continued device development.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Hemodynamic Instability
Not yet recruiting
Dexametedomidine Ketamine Infusion Versus Dexametedomidine Propofol Infusion in Non-compliant Agitated Patients on Continuous Positive Airway Pressure (CPAP) Mask Ventilation in the Intensive Care Unit
CPAP Ventilation, Sedation
RecruitingObservational study
Machine Learning-Assisted Management of Intraoperative Hypotension for Personalized Treatment
Intraoperative Hypotension, Perioperative Care
Not yet recruitingObservational study
Development and Internal Validation of a Multimodal Prediction Score for Early Hemodynamic Deterioration in Adult Polytrauma Patients
Multiple Trauma, Polytrauma
RecruitingObservational study
Internal Jugular Vein Ultrasound and Acute Kidney Injury After Abdominal Surgery
Intraoperative Hypotension, Jugular Veins
Not yet recruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodynamic Instability, run by Becton, Dickinson and Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristina Johnson (949-308-5850, apmhsalta.study@bd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Data Collection using HemoSphere Alta Advanced Monitoring Platform and associated devices (time frame: Up to 72 hours of device data collection during surgery and ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.