Measurement of the performance of the heart
Conditions
Interventions
None listed
Sponsors
Edwards Lifesciences LLC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patient must have an indwelling pulmonary artery catheter and either a radial or a femoral or other arterial catheter in order to participate in the study. Patient will have the pulmonary artery catheter remain in-situ for a minimum of 8 hours after study initiation. Patient is able to comply with the study procedure. Patient, guardian or person authorized with power of attorney to give informed consent prior to placement of indwelling catheters according to applicable country specific law. Patient must be 18 years old or older. Ability to obtain an accurate subject height and weight prior to study start and as required during the study period.
Exclusion criteria
Exclusion criteria: Patients with contraindications for the placement of radial, femoral or other arterial cannulae. Patients with aortic valve regurgitation Patients being treated with an intraaortic balloon pump. Patients less than 40 kg in weight. Pronounced cardiac arrhythmia (such as bigeminy). Female patients of childbearing potential with a known pregnancy. Any contraindications for the type of COCD being evaluated. The subject is currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the study endpoints. (Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available are not considered investigational trials.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intermittent Cardiac Output (ICO) Continuous Cardiac Output (CCO) | — |
Secondary
| Measure | Time frame |
|---|---|
| Demographics, Reason for Hemodynamic monitoring, Pre-existing conditions, Heart rate, Arterial Pressure, systemic Vascular Resistance, Ease of Use, Adverse Events, Termination from the study, and Definition of competitive cardiac output technology. | — |
Countries
Netherlands
Outcome results
None listed