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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Cohort (Swan) | Up to 100 subjects with planned monitoring with a pulmonary artery catheter in the OR. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Data Collection using HemoSphere Alta Advanced Monitoring Platform and associated devices | Number of patients who receive monitoring using the HemoSphere Alta Advanced Monitoring Platform and associated devices for continued device development. | Up to 72 hours of device data collection during surgery and ICU |
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Inclusion Criteria:
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
Additional criteria for Sub-Cohort A (RVF)
Additional criteria for Sub-Cohort B (CAI)
Exclusion Criteria:
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
Additional exclusion criteria for Sub-Cohort A
Additional exclusion criteria for Sub-Cohort B a. Surgery for congenital heart defect
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Up to 100 subjects with planned monitoring with a pulmonary artery catheter in the Operating Room (OR). Subjects must meet the eligibility criteria for the Primary Cohort to be enrolled in the study. Subjects may further qualify for inclusion in Sub-Cohorts A and/or B.
Sub-Cohort A Right Ventricular Failure (RVF) will include up to 25 subjects undergoing either non-cardiac or cardiac surgery with a planned transesophageal echocardiogram (TEE) assessment.
Sub-Cohort B Cerebral Autoregulation Index (CAI) will include up to 50 subjects aged ≥ 45 years undergoing Cardiopulmonary Bypass (CPB) with the ability to place ForeSight and Acumen IQ sensors and are at high risk for cerebrovascular disease.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14620 | United States |
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