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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00468247




Registration number
NCT00468247
Ethics application status
Date submitted
30/04/2007
Date registered
2/05/2007
Date last updated
25/04/2008

Titles & IDs
Public title
Registration Enabling Study of the Safety and Efficacy of the Use of the Navigator Circulatory Management System
Scientific title
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)
Secondary ID [1] 0 0
AP2006-01
Universal Trial Number (UTN)
Trial acronym
NAV-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 0 0
Intensive Care 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Navigator
Other interventions - Conventional care

Active Comparator: 1 - Device , Navigator used for guiding haemodynamic care

Placebo Comparator: 2 - Conventional care


Treatment: Devices: Navigator
Navigator circulatory mgt system

Other interventions: Conventional care
Conventional haemodynamic care
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Average distance to central point of the target cardiovascular zone while connected to the device
Timepoint [1] 0 0
Time connected to Navigator device
Secondary outcome [1] 0 0
Percentage time in the target cardiovascular zone while connected to device
Timepoint [1] 0 0
Time connected to Navigator device
Secondary outcome [2] 0 0
Clinically significant AF while connected to device
Timepoint [2] 0 0
Time connected to Navigator device
Secondary outcome [3] 0 0
Multiple organ function (SOFA score)
Timepoint [3] 0 0
From connection to Navigator device to hospital discharge
Secondary outcome [4] 0 0
Device-related adverse events and device failures
Timepoint [4] 0 0
Time connected to Navigator device

Eligibility
Key inclusion criteria
1. Male or female aged 18 years or older

2. Undergoing elective cardiac surgery where surgery involves the use of a heart-lung
perfusion pump

3. Will have an arterial line and Swan Ganz catheter in situ

4. Require invasive measurement of Cardiac Output (CO), Mean Arterial Pressure (MAP) and
Right Atrial Pressure (RAP)

5. Are able and willing to provide written informed consent to participate in the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women who are lactating or pregnant

2. Require Extracorporeal Membrane Oxygenation

3. 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)

4. Intra-operative surgical treatment for atrial fibrillation

5. Surgery for left atrial reduction

6. Patients with left ventricular assist devices

7. Patients with permanent pacemakers in situ

8. Deemed by the investigator to be uncooperative or unsuitable for inclusion into this
trial

9. Have a medical condition that in the opinion of the investigator would jeopardise the
patient's safety by participating in this trial

10. Current participation in another drug or device study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2008
Sample size
Target
Accrual to date
Final
112
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
St Vincent's Public Hospital - Sydney
Recruitment hospital [2] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [3] 0 0
Westmead Private Hospital - Sydney
Recruitment hospital [4] 0 0
Westmead Public Hospital - Sydney
Recruitment hospital [5] 0 0
St George Public Hospital - Sydney
Recruitment hospital [6] 0 0
Monash Medical Centre - Melbourne
Recruitment hospital [7] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
2065 - Sydney
Recruitment postcode(s) [3] 0 0
2145 - Sydney
Recruitment postcode(s) [4] 0 0
2217 - Sydney
Recruitment postcode(s) [5] 0 0
3168 - Melbourne
Recruitment postcode(s) [6] 0 0
3181 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Applied Physiology Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Trident Clinical Research Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
A multicentre, open, RCT to assess the safety and efficacy of the Navigator Guided
Circulatory Management System versus conventional care in post-operative cardiac surgery
patients. The purpose of the study is to demonstrate that the real time acquisition and
subsequent processing and display of data produced by the Navigator guided circulatory
management system provides the clinician with appropriate data and guidance to achieve and
maintain a prescribed target haemodynamic stability in the post operative patient when
compared to conventional care in an Intensive Care Unit setting.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00468247
Trial related presentations / publications
Parkin WG. Volume state control - a new approach. Crit Care Resusc. 1999 Sep;1(3):311-21.
Public notes

Contacts
Principal investigator
Name 0 0
Yugan Mudaliar, PhD
Address 0 0
Western Sydney Area Health Service
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00468247