HemoSphere Alta advanced hemodynamic and cerebral monitoring during transplant and cardiac surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, non-randomized single-arm observational effort that collects device and physiologic data from adult patients monitored with the HemoSphere Alta platform and associated sensors during cardiac or liver transplant operations. Enrolled subjects will have planned pulmonary artery catheter monitoring and procedures expected to last more than two hours, with additional predefined sub-cohorts for possible right ventricular failure (based on pre-op TTE and planned intraoperative TEE) and for cerebral autoregulation impairment risk (older adults having cardiac surgery with cardiopulmonary bypass and placement of ForeSight IQ/Acumen IQ sensors). Data are collected intraoperatively and postoperatively for continual device development and algorithm refinement rather than to test a randomized intervention. The protocol documents device use, signal capture, and clinical context to support future product improvements.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Rochester Medical Center
  Rochester, New York, United States Recruiting

Study contacts

• Study coordinator: Cristina Johnson
• Email: apmhsalta.study@bd.com
• Phone: 949-308-5850

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.