Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000085471
Ethics application status
Approved
Date submitted
20/09/2006
Date registered
25/01/2007
Date last updated
25/01/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to assess the safety and efficacy of Navigator in post operative cardiac surgery patients versus conventional care.
Scientific title
AP2006-1: A prospective, randomised, multicentre, controlled group study to assess the safety and efficacy of Navigator versus conventional care in post operative cardiac surgery patients undergoing coronary bypass grafting and / or heart valve repair or replacement whilst utilising heart lung perfusion pump.
Universal Trial Number (UTN)
Trial acronym
NAV-1 Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elective cardiac bypass grafting and / or heart valve repair or replacement whilst utilising heart lung perfusion pump. 1578 0
Condition category
Condition code
Cardiovascular 1680 1680 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Post operative cardiac patients entering the Intensive Care will be connected to the Navigator device with real-time data displayed in a graphical manner. The Navigator device will be connected until the Swan-Ganz catheter is removed. This is most commonly on day 2 after surgery, but could be as long as 7 days.
Intervention code [1] 1352 0
Other interventions
Comparator / control treatment
Post operative cardiac patients entering the Intensive Care will be connected to the Navigator device but without real-time data displayed in a graphical manner. The Navigator device will be connected until the Swan-Ganz catheter is removed. This is most commonly on day 2 after surgery, but could be as long as 7 days.
Control group
Active

Outcomes
Primary outcome [1] 2325 0
Average distance to the central point of the physician-prescribed target cardiovascular zone over the period that the patient is connected to Navigator.
Timepoint [1] 2325 0
This will most commonly be on day 2 after surgery, but, dependent on speed of recovery, may be up to and beyond 7 days.
Secondary outcome [1] 4060 0
1) Percentage time in the physician-nominated target cardiovascular zone
Timepoint [1] 4060 0
over the period of time that the patient is connected to Navigator, usually over 2 days, but may be up to or more than 7 days
Secondary outcome [2] 4061 0
2) clinically significant atrial fibrillation (AF)
Timepoint [2] 4061 0
over the period the patient is connected to Navigator, usually for 2 days post-surgery, but may be up to or more than 7 days, depending on speed of recovery
Secondary outcome [3] 4062 0
3) Multiple organ function, as assessed using the SOFA score
Timepoint [3] 4062 0
calculated daily over the period the patient is hospitalised, usually for 5 days, but could be up to 10 days in cases of slow recovery
Secondary outcome [4] 4063 0
4) Navigator device related adverse events and device failures.
Timepoint [4] 4063 0

Eligibility
Key inclusion criteria
Who provide written informed consent and are about to undergo elective heart surgery requiring heart lung perfusion pump. Eligible patients will emerge from surgery with an arterial line and Swan Ganz catheter in situ and must require invasive measurement of cardiac output, mean arterial pressure and right atrial pressure.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will not be eligible for inclusion if the require extracorporeal membrane oxygenation, or have permenant pace makers or left ventircular assist devices in situ. A history of or pre-randomisation event of atrial fibrillation and/or intra-operative surgical treatment for atrial fibrillation will exclude patients from the study. Simillarly if the investigator deems the patient unco-operative or unsuitable for inclusion or considers an exisiting medical condition renders participation unsafe for the patient they will be excluded from the study. Patients will also be excluded if they are involved in another drug/device study or if they are pregnant or lactating females.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central Randomisation by Phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
1:1 randomisation using a computer generated randomisation table and stratified by site and history of atrial fibrillation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
multi-centre
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/10/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1825 0
Commercial sector/Industry
Name [1] 1825 0
Applied Physiology Pty Limited
Country [1] 1825 0
Primary sponsor type
Commercial sector/Industry
Name
Applied Physiology Pty Limited
Address
119 Willoughby Road
Crows Nest NSW 2065
Country
Australia
Secondary sponsor category [1] 1645 0
None
Name [1] 1645 0
Nil
Address [1] 1645 0
Country [1] 1645 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3416 0
St George Hospital, Sydney
Ethics committee address [1] 3416 0
Ethics committee country [1] 3416 0
Australia
Date submitted for ethics approval [1] 3416 0
Approval date [1] 3416 0
14/11/2006
Ethics approval number [1] 3416 0
2006/100 Horton
Ethics committee name [2] 3417 0
Alfred Hospital, Melbourne
Ethics committee address [2] 3417 0
Ethics committee country [2] 3417 0
Australia
Date submitted for ethics approval [2] 3417 0
Approval date [2] 3417 0
08/01/2007
Ethics approval number [2] 3417 0
229/06
Ethics committee name [3] 3418 0
St Vincent's Hospital, Sydney
Ethics committee address [3] 3418 0
Ethics committee country [3] 3418 0
Australia
Date submitted for ethics approval [3] 3418 0
Approval date [3] 3418 0
27/11/2006
Ethics approval number [3] 3418 0
H06/127

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27959 0
Address 27959 0
Country 27959 0
Phone 27959 0
Fax 27959 0
Email 27959 0
Contact person for public queries
Name 10541 0
Louise Hayman, Senior Partner
Address 10541 0
Trident Clinical Research Pty Limited, Suite 204, 27 Merriwa Street, Gordon, NSW 2072
Country 10541 0
Australia
Phone 10541 0
+61 2 94999996
Fax 10541 0
+61 2 94999998
Email 10541 0
[email protected]
Contact person for scientific queries
Name 1469 0
Dr Geoffrey Parkin
Address 1469 0
Medical Director, Applied Physiology Pty Limited, 119 Willoughby Road, Crows Nest, NSW 2065
Country 1469 0
Australia
Phone 1469 0
+61 418582281
Fax 1469 0
+61 2 94392157
Email 1469 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.