HemoSphere Alta Study
ConditionHemodynamic Instability
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEdwards Lifesciences
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- HemoSphere Alta Monitor, Swan-Ganz IQ pulmonary arterial catheter, ForeSight IQ Large sensor, and Acumen IQ sensor
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov