HemoSphere Alta Study

Running, not enrolling

Conditions studied: Hemodynamic Instability

In brief

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.

Key facts

Study ID

NCT07148323

Run by

Becton, Dickinson and Company

People needed

100

Starts

2025-10-14

Expected to finish

2026-12-01

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• 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

You may not qualify if…

• 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
• 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

Where it is running

• University of Rochester Medical Center — Rochester, New York, United States

Full record on ClinicalTrials.gov

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