Status:
RECRUITING
HemoSphere Alta Study
Lead Sponsor:
Edwards Lifesciences
Conditions:
Hemodynamic Instability
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 14 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07148323
Start Date
October 14 2025
End Date
December 1 2026
Last Update
November 10 2025
Active Locations (1)
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1
University of Rochester Medical Center
Rochester, New York, United States, 14620