NL-OMON29845
Withdrawn
Not Applicable
PERFORMANCE EVALUATION OF ARTERIAL PRESSURE CARDIAC OUTPUT SYSTEMS AS COMPARED TO STANDARD THERMODILUTION AND OTHER ALTERNATIVE CARDIAC OUTPUT MEASUREMENTS Protocol Number: 2005-03 Revision C Effective date: February 10, 2006 - MASTERMIND
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Edwards Lifesciences LLC
- Enrollment
- 20
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.)
Outcomes
Primary Outcomes
Not specified
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