HemoSphere Alta Study

NCT07148323 | Recruiting FDA Device

• 1 other identifier: 2025-05
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodynamic Instability

Outcome Measures

Primary Outcomes (1)

• Data Collection using HemoSphere Alta Advanced Monitoring Platform and associated devices

  Number of patients who receive monitoring using the HemoSphere Alta Advanced Monitoring Platform and associated devices for continued device development.

  Up to 72 hours of device data collection during surgery and ICU

Study Arms (1)

Primary Cohort (Swan)

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

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

Interventions

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

Subjects with planned monitoring with a pulmonary artery catheter in the operating room, will be monitored with the above listed devices.

Primary Cohort (Swan)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Up to 100 subjects with planned monitoring with a pulmonary artery catheter in the Operating Room (OR). Subjects must meet the eligibility criteria for the Primary Cohort to be enrolled in the study. Subjects may further qualify for inclusion in Sub-Cohorts A and/or B. Sub-Cohort A Right Ventricular Failure (RVF) will include up to 25 subjects undergoing either non-cardiac or cardiac surgery with a planned transesophageal echocardiogram (TEE) assessment. Sub-Cohort B Cerebral Autoregulation Index (CAI) will include up to 50 subjects aged ≥ 45 years undergoing Cardiopulmonary Bypass (CPB) with the ability to place ForeSight and Acumen IQ sensors and are at high risk for cerebrovascular disease.

You may qualify if:

• Signed informed consent
• Age ≥ 18 years
• Planned monitoring with a pulmonary artery catheter
• Patient scheduled to undergo cardiac or liver transplant surgery lasting \> 2 hours
• Additional criteria for Sub-Cohort A (RVF)
• Possible Right Ventricular Dysfunction/Failure based on pre-operative assessment of previous Transthoracic Echocardiogram (TTE)
• Planned Transesophageal Echocardiogram (TEE) assessment during the operative procedure
• Additional criteria for Sub-Cohort B (CAI)
• Age ≥ 45 years
• Planned cardiac surgery with Cardiopulmonary Bypass (CPB)
• Ability to place ForeSight IQ and Acumen IQ sensors during the operative monitoring period
• 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

You may not qualify if:

• Inability to provide informed consent
• Pregnancy as confirmed per EMR
• Patients deemed not suitable for the study at the discretion of the Investigator
• Participation in another study that clinically interferes with the current study
• Presence of left bundle branch block
• Presence of current/recurrent sepsis
• Presence of hypercoagulability, as identified in the patient's past medical history and preoperative evaluation
• Structural abnormality, including congenital heart defects, of the right ventricle

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14620, United States

RECRUITING

Central Study Contacts

Cristina Johnson

CONTACT

949-308-5850; apmhsalta.study@bd.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 29, 2025
• Study Start: October 14, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)