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

HemoSphere Alta Clinical Development Study

This project will test the HemoSphere Alta monitoring platform with a pulmonary artery catheter plus brain and hemodynamic sensors in adults having cardiac or liver transplant surgery who need advanced intraoperative monitoring.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Edwards Lifesciences (industry)
• Locations: 1 site (Rochester, New York)
• Trial ID: NCT07148323 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18 or older scheduled for cardiac or liver transplant surgery lasting more than two hours with planned pulmonary artery catheter monitoring — including specified subcohorts for suspected right ventricular dysfunction or for cardiac surgery patients at high risk for cerebral vascular disease — are ideal candidates.

Not a fit: Patients who are under 18, who do not require invasive pulmonary artery catheter monitoring, or who undergo shorter or nonoperative procedures are unlikely to receive direct benefit from participating.

Why it matters

Potential benefit: If successful, the collected data could help improve real-time hemodynamic and cerebral monitoring during high-risk cardiac and liver transplant procedures so clinicians detect and respond to instability earlier.

How similar studies have performed: Related monitoring technologies (pulmonary artery catheters, cerebral oximetry, and Acumen sensors) have been used clinically and studied previously with mixed but informative results, while collection of integrated Alta platform data for iterative device development is a newer, less-tested approach.

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

Where this trial is running

Rochester, New York

• University of Rochester Medical Center — Rochester, New York, United States (RECRUITING)

Study contacts

• Study coordinator: Cristina Johnson

Conditions: Hemodynamic Instability