The purpose of this study is to evaluate accuracy of Cardiac Output measurements by comparing the Cardiac Output calculated by Arterial Pressure based Cardiac Output (APCO) and by other well accepted indicator dilution techniques, as well by…
ID
Source
Brief title
Condition
- Heart failures
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Intermittent Cardiac Output (ICO)
Continuous Cardiac Output (CCO)
Secondary outcome
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.
Background summary
MASTERMIND
Performance Evaluation of Arterial Pressure Cardiac Output Systems as Compared
to Standard Thermodilution and other Alternative Cardiac Output Measurements.
Sponsor:
Edwards Lifesciences LLC
One Edwards Way
Irvine, CA 92614 USA
The FloTrac Sensor is a less invasive hemodynamic monitoring device that, when
used with the Vigileo monitor, measures continuous cardiac output (CCO) through
an arterial pressure line.
Study objective
The purpose of this study is to evaluate accuracy of Cardiac Output
measurements by comparing the Cardiac Output calculated by Arterial Pressure
based Cardiac Output (APCO) and by other well accepted indicator dilution
techniques, as well by competitive technology and devices (COCD).
Study design
This is a prospective, paired sample comparison study that will be conducted at
various sites located throughout Europe.
Study burden and risks
No burden or risks considered associated with participation.
This will be an observation study.
One Edwards Way
Irvine, CA 92614
USA
One Edwards Way
Irvine, CA 92614
USA
Listed location countries
Age
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.)
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL12988.058.06 |