RecruitingNCT07148323

HemoSphere Alta Study

HemoSphere Alta Clinical Development Study

Sponsor

Edwards Lifesciences

Enrollment

100 participants

Start Date

Oct 14, 2025

Study Type

OBSERVATIONAL

Conditions

Hemodynamic Instability

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria12

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

Exclusion Criteria8

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
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

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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.

Locations(1)

University of Rochester Medical Center

Rochester, New York, United States

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NCT07148323

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