HemoSphere Alta Study

August 24, 2026 updated by: Becton, Dickinson and Company

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14620
        • Recruiting
        • University of Rochester Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

Inclusion Criteria:

  1. Signed informed consent
  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, transient ischemic attack, carotid bruit, tobacco smoking, or peripheral vascular disease

Exclusion Criteria:

  1. Inability to provide informed consent
  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 72 hours of device data collection during surgery and ICU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Becton, Dickinson and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

August 13, 2025

First Submitted That Met QC Criteria

August 26, 2025

First Posted (Actual)

August 29, 2025

Study Record Updates

Last Update Posted (Actual)

August 26, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2025-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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