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RecruitingNCT07148323Updated Aug 26, 2026

HemoSphere Alta Study

An observational study in Hemodynamic Instability, sponsored by Becton, Dickinson and Company. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by Becton, Dickinson and Company · Observational

From the registry’s dates

  • Started Oct 2025; still recruiting 1 year later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hemodynamic Instability
03

In context

Lead sponsor

Becton, Dickinson and Company is the lead sponsor of 61 studies on the registry; 5 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.

Browse Becton, Dickinson and Company studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Signed
  2. Age ≥ 18 years
  3. Planned monitoring with a pulmonary artery catheter
  4. Patient scheduled to undergo cardiac or liver transplant surgery lasting > 2 hours

  5. Additional criteria for Sub-Cohort A (RVF)

    1. Possible Right Ventricular Dysfunction/Failure based on pre-operative assessment of previous Transthoracic Echocardiogram (TTE)
    2. Planned Transesophageal Echocardiogram (TEE) assessment during the operative procedure

  6. Additional criteria for Sub-Cohort B (CAI)

    1. Age ≥ 45 years
    2. Planned cardiac surgery with Cardiopulmonary Bypass (CPB)
    3. Ability to place ForeSight IQ and Acumen IQ sensors during the operative monitoring period
    4. High risk for cerebral vascular disease, defined as: a history of hypertension, pulse pressure > 60 mmHg, diabetes, stroke, , carotid bruit, tobacco smoking, or peripheral vascular disease

Exclusion criteria

Exclusion Criteria:

  1. Inability to provide
  2. Pregnancy as confirmed per EMR
  3. Patients deemed not suitable for the study at the discretion of the Investigator
  4. Participation in another study that clinically interferes with the current study

  5. Additional exclusion criteria for Sub-Cohort A

    1. Presence of left bundle branch block
    2. Presence of current/recurrent sepsis
    3. Presence of hypercoagulability, as identified in the patient's past medical history and preoperative evaluation
    4. Structural abnormality, including congenital heart defects, of the right ventricle
  6. Additional exclusion criteria for Sub-Cohort B a. Surgery for congenital heart defect
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • Primary Cohort (Swan)

    Up to 100 subjects with planned monitoring with a pulmonary artery catheter in the OR.

    Device: HemoSphere Alta Monitor, Swan-Ganz IQ pulmonary arterial catheter, ForeSight IQ Large sensor, and Acumen IQ sensor

Interventions

  • DeviceHemoSphere Alta Monitor, Swan-Ganz IQ pulmonary arterial catheter, ForeSight IQ Large sensor, and Acumen IQ sensor

    Subjects with planned monitoring with a pulmonary artery catheter in the operating room, will be monitored with the above listed devices.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 72 hours of device data collection during surgery and ICU

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2025 (actual). Primary completion is estimated for Nov 2026, 13 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 13, 2025
First posted
Aug 29, 2025
StartActual
Oct 14, 2025
Primary completionEst.
Nov 2026
CompletionEst.
Dec 2026
Last update
Aug 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07148323
Lead sponsor
Becton, Dickinson and Company
Responsible party
Sponsor
First posted
Aug 29, 2025
Start date
Oct 14, 2025
Primary completion
Nov 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Aug 26, 2026

Study contacts

Cristina Johnson
Contact
apmhsalta.study@bd.com
949-308-5850

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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