- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00468247
Registration Enabling Study of the Safety and Efficacy of the Use of the Navigator Circulatory Management System (NAV-1)
A Prospective,Open,Multicentre,RCT to Assess the Safety & Efficacy of Navigator v Conventional Care in Post-op Cardiac Surgery Patients Undergoing CABG &/or Heart Valve Repair/Replacement Utilising Heart Lung Perfusion Pump(The NAV-1 Study)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Protocol No. AP2006-01
Study title: A Prospective, Open, Randomised, Multicentre, Controlled Group Study to Assess the Safety and Efficacy of Navigator versus Conventional Care in Postoperative Cardiac Surgery Patients Undergoing Coronary Bypass Grafting and or Heart Valve Repair or Replacement Utilizing Heart Lung Perfusion Pump.
Acronym: NAV 1
Type of study: Device Trial
Sponsor: Applied Physiology Pty Ltd
Study device: Navigator Guided Circulatory Care Management System
Route of Administration: Via Touch Panel Computer, externally connected to the bedside physiological monitor in a critical care environment
Study centres: Six Australian centres
Study design: Multicentre, open, randomised, controlled group study
Total sample size: One hundred completed patients, 50 in each arm
Study population: Post operative coronary bypass and heart valve repair or replacement patients admitted to a Cardiac Intensive Care or Intensive Care Unit. Surgery must involve the use of a heart lung perfusion pump and the patient must have a functioning arterial line and Swan Ganz catheter in situ to enable the measurement of Cardiac Output, Mean Arterial Pressure, and Right Atrial Pressure.
Study regimen: Following surgery, and after meeting inclusion and exclusion criteria, patients will be randomised on admission to ICU to receive care guided by Navigator or conventional care during their ICU stay while CO is being monitored. All patients will be connected to the Navigator; the screen of the patients in the control group will have the graphical section blank, the right hand side will display actual values of MAP, CO and RAP as slaved from the bedside monitor, along with the patient's screening and randomisation number and initials. The arm of the study to which the patient has been randomised ;control/Navigator, will also be shown.
Endpoints:
Primary: The primary efficacy endpoint is the average distance to the central point of the target cardiovascular zone over the period the patient is connected to Navigator.
Secondary: Secondary endpoints for the trial will be:
- Percentage time in the target cardiovascular zone over the period the patient is connected to the Navigator
- Clinically significant atrial fibrillation over the period the patient is connected to the Navigator. This is defined as irregular supraventricular rhythm with an absence of discrete P waves lasting more than ten minutes documented and confirmed with an ECG
- Multiple organ function, as assessed using the SOFA score, calculated daily
- Navigator device related adverse events and device failures
Statistical analysis: The primary and secondary endpoints and all safety data will be analysed on the randomised Intention-to-treat population.The ITT population will include all individuals who are randomised. The analysis will compare the primary efficacy endpoint between the two randomised treatment groups using independent t tests. The secondary analyses will compare the secondary endpoints between the two randomised treatment groups using independent t-tests, Chi-square tests and Fisher's exact tests as appropriate.
Study Period: From the first pre-surgery screening visit to the post operative follow up visit, approximately six weeks
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New South Wales
-
Sydney, New South Wales, Australia, 2065
- Royal North Shore Hospital
-
Sydney, New South Wales, Australia, 2010
- St Vincent's Public Hospital
-
Sydney, New South Wales, Australia, 2145
- Westmead Private Hospital
-
Sydney, New South Wales, Australia, 2145
- Westmead Public Hospital
-
Sydney, New South Wales, Australia, 2217
- St George Public Hospital
-
-
Victoria
-
Melbourne, Victoria, Australia, 3168
- Monash Medical Centre
-
Melbourne, Victoria, Australia, 3181
- The Alfred Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female aged 18 years or older
- Undergoing elective cardiac surgery where surgery involves the use of a heart-lung perfusion pump
- Will have an arterial line and Swan Ganz catheter in situ
- Require invasive measurement of Cardiac Output (CO), Mean Arterial Pressure (MAP) and Right Atrial Pressure (RAP)
- Are able and willing to provide written informed consent to participate in the study
Exclusion Criteria:
- Women who are lactating or pregnant
- Require Extracorporeal Membrane Oxygenation
- Present at baseline screening or immediately prior to randomisation in the ICU with atrial fibrillation (irregular supraventricular rhythm, not due to ectopic complexes with an absence of discrete P-waves lasting more than 10 minutes documented and confirmed with an ECG)
- Intra-operative surgical treatment for atrial fibrillation
- Surgery for left atrial reduction
- Patients with left ventricular assist devices
- Patients with permanent pacemakers in situ
- Deemed by the investigator to be uncooperative or unsuitable for inclusion into this trial
- Have a medical condition that in the opinion of the investigator would jeopardise the patient's safety by participating in this trial
- Current participation in another drug or device study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Device , Navigator used for guiding haemodynamic care
|
Navigator circulatory mgt system
|
Placebo Comparator: 2
Conventional care
|
Conventional haemodynamic care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Average distance to central point of the target cardiovascular zone while connected to the device
Time Frame: Time connected to Navigator device
|
Time connected to Navigator device
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage time in the target cardiovascular zone while connected to device
Time Frame: Time connected to Navigator device
|
Time connected to Navigator device
|
Clinically significant AF while connected to device
Time Frame: Time connected to Navigator device
|
Time connected to Navigator device
|
Multiple organ function (SOFA score)
Time Frame: From connection to Navigator device to hospital discharge
|
From connection to Navigator device to hospital discharge
|
Device-related adverse events and device failures
Time Frame: Time connected to Navigator device
|
Time connected to Navigator device
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Yugan Mudaliar, PhD, Western Sydney Area Health Service
- Study Director: Geoff Parkin, PhD, Monash Medical Centre
Publications and helpful links
General Publications
- Parkin WG. Volume state control - a new approach. Crit Care Resusc. 1999 Sep;1(3):311-21.
- Pellegrino VA, Mudaliar Y, Gopalakrishnan M, Horton MD, Killick CJ, Parkin WG, Playford HR, Raper RF. Computer based haemodynamic guidance system is effective and safe in management of postoperative cardiac surgery patients. Anaesth Intensive Care. 2011 Mar;39(2):191-201. doi: 10.1177/0310057X1103900207.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AP2006-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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