Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2025-10-14
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Primary Cohort (Swan)
Up to 100 subjects with planned monitoring with a pulmonary artery catheter in the OR.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
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
18 Years
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Responsible Party
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Locations
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University of Rochester Medical Center
Rochester, New York, United States
Countries
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Central Contacts
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Other Identifiers
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2025-05
Identifier Type: -
Identifier Source: org_study_id