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Active, Not Recruiting

NCT Number: NCT07148323

HemoSphere Alta Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hemodynamic Instability

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Rochester Medical Center

Rochester, New York, 14620, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Additional exclusion criteria for Sub-Cohort A
  • 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
  • Additional exclusion criteria for Sub-Cohort B a. Surgery for congenital heart defect

Treatment and study plan

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 outcomes

  1. Data Collection using HemoSphere Alta Advanced Monitoring Platform and associated devices

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Becton, Dickinson and Company

Industry

Registry information

Official study title

HemoSphere Alta Clinical Development Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 29, 2025
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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