RecruitingNCT07148323
HemoSphere Alta Study
HemoSphere Alta Clinical Development Study
Sponsor
Edwards Lifesciences
Enrollment
100 participants
Start Date
Oct 14, 2025
Study Type
OBSERVATIONAL
Conditions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07148323
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