Actively Recruiting
HemoSphere Alta Study
Led by Edwards Lifesciences · Updated on 2025-11-10
100
Participants Needed
1
Research Sites
59 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
HemoSphere Alta Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Age 18 years or older
- Planned monitoring with a pulmonary artery catheter
- Scheduled for cardiac or liver transplant surgery lasting more than 2 hours
- For Sub-Cohort A (RVF): Possible right ventricular dysfunction/failure based on previous transthoracic echocardiogram and planned transesophageal echocardiogram during surgery
- For Sub-Cohort B (CAI): Age 45 years or older, planned cardiac surgery with cardiopulmonary bypass, ability to place ForeSight IQ and Acumen IQ sensors during surgery, high risk for cerebral vascular disease defined by history of hypertension, pulse pressure > 60 mmHg, diabetes, stroke, transient ischemic attack, carotid bruit, tobacco smoking, or peripheral vascular disease
You will not qualify if you...
- Inability to provide informed consent
- Pregnancy confirmed by medical record
- Patients deemed unsuitable for the study by the Investigator
- Participation in another study that clinically interferes with this study
- For Sub-Cohort A: Presence of left bundle branch block, current or recurrent sepsis, history of hypercoagulability, structural abnormalities of the right ventricle including congenital heart defects
- For Sub-Cohort B: Surgery for congenital heart defect
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Rochester Medical Center
Rochester, New York, United States, 14620
Actively Recruiting
Research Team
C
Cristina Johnson
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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