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HemoSphere Alta Study

RecruitingObservational study

HemoSphere Alta Clinical Development Study

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

1. Signed informed consent
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:

1. Inability to provide informed consent
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
5. Additional exclusion criteria for Sub-Cohort A

   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
6. Additional exclusion criteria for Sub-Cohort B a. Surgery for congenital heart defect

About the study

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.

What is being tested

Sponsor: Becton, Dickinson and Company · Participants: 100 · Started: Oct 14, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07148323

Locations in the U.S.

New YorkUniversity of Rochester Medical Center, Rochester

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.