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

Withdrawn

• Conditions: Measurement of the performance of the heart; 10019280; 10007593

• Registration Number: NL-OMON29845
• Lead Sponsor: Edwards Lifesciences LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 20

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.)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified