HemoSphere Alta Study

Edwards Lifesciences

Status: Enrolling

Conditions: Hemodynamic Instability

Treatments: Device: HemoSphere Alta Monitor, Swan-Ganz IQ pulmonary arterial catheter, ForeSight IQ Large sensor, and Acumen IQ sensor

Study type: Observational

Funder types: Industry

Identifiers

NCT07148323

2025-05

Details and patient eligibility

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Primary Cohort (Swan)

Description:

Up to 100 subjects with planned monitoring with a pulmonary artery catheter in the OR.

Treatment:

Device: HemoSphere Alta Monitor, Swan-Ganz IQ pulmonary arterial catheter, ForeSight IQ Large sensor, and Acumen IQ sensor