HemoSphere Alta Study

Part of paid clinical trials in Rochester, New York.

Sponsor
Edwards Lifesciences
Study ID
NCT07148323
Status
Recruiting
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Conditions

  • Hemodynamic Instability

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Oct 14, 2025
Status verified
Nov 2025
Primary completion
Nov 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Primary Cohort (Swan)
    Up to 100 subjects with planned monitoring with a pulmonary artery catheter in the OR.

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Rochester Medical CenterRochesterNew York14620-

Find similar trials in Rochester, NY

By research site
University of Rochester Medical Center· Rochester, NY

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