HemoSphere Alta Study

Not yet recruiting

• Conditions: Hemodynamic Instability

• Registration Number: NCT07148323
• Lead Sponsor: Edwards Lifesciences

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-13
• Study First Submitted QC: 2025-08-26
• Last Update Submitted: 2025-08-26
• Study First Posted: 2025-08-29
• Last Update Posted: 2025-08-29
• Study Start: 2025-09-01
• Primary Completion: 2026-09
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Data Collection using HemoSphere Alta Advanced Monitoring Platform and associated devices	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.