NCT07148323RecruitingNot Applicable
HemoSphere Alta Clinical Development Study
Becton, Dickinson and Company1 site in 1 country100 target enrollmentStarted: October 14, 2025Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Data Collection using HemoSphere Alta Advanced Monitoring Platform and associated devices
Study Overview
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 for continual device development purposes.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Primary Cohort (Swan)
Up to 100 subjects with planned monitoring with a pulmonary artery catheter in the OR.
Intervention: HemoSphere Alta Monitor, Swan-Ganz IQ pulmonary arterial catheter, ForeSight IQ Large sensor, and Acumen IQ sensor (Device)
Outcomes
Primary Outcomes
Data Collection using HemoSphere Alta Advanced Monitoring Platform and associated devices
Time Frame: Up to 72 hours of device data collection during surgery and ICU
Number of patients who receive monitoring using the HemoSphere Alta Advanced Monitoring Platform and associated devices for continued device development.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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