HemoSphere Alta Clinical Development Study
Edwards Lifesciences
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Signed informed consent 2. Age ≥ 18 years 3. Planned monitoring with a pulmonary artery catheter 4. Patient scheduled to undergo cardiac or liver transplant surgery lasting \> 2 hours 5. Additional criteria for Sub-Cohort A (RVF) 1. Possible Right Ventricular Dysfunction/Failure based on pre-operative assessment of previous Transthoracic Echocardiogram (TTE) 2. Planned Transesophageal Echocardiogram (TEE) assessment during the operative procedure 6. Additional criteria for Sub-Cohort B (CAI) 1. Age ≥ 45 years 2. Planned cardiac surgery with Cardiopulmonary…
Interventions
- DeviceHemoSphere 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.
Location
- University of Rochester Medical CenterRochester, New York