Trials / Recruiting
RecruitingNCT07148323
HemoSphere Alta Study
HemoSphere Alta Clinical Development Study
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- Edwards Lifesciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-10-14
- Primary completion
- 2026-11-01
- Completion
- 2026-12-01
- First posted
- 2025-08-29
- Last updated
- 2025-11-10
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07148323. Inclusion in this directory is not an endorsement.