Recruiting

HemoSphere Alta

Sponsor:

Becton, Dickinson and Company

Code:

NCT07148323

Conditions

Hemodynamic Instability

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief 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.

Conditions

Hemodynamic Instability

Study ID

NCT07148323

Start date

Oct 14, 2025

Status verified date

Aug, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Primary Cohort (Swan)

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

Interventions

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.

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 ]

Central Contacts and Locations

Central contacts

Locations

University of Rochester Medical Center

Recruiting

Rochester, New York, United States, 14620

More Information

Sponsor

Becton, Dickinson and Company

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Becton, Dickinson and Company on 2026-08-26.