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HemoSphere Alta Study

NCT07148323 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-11-10

No results posted yet for this study

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

Interventions

DEVICE

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

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

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-14
Primary Completion
2026-11-30
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07148323 on ClinicalTrials.gov