Registration Enabling Study of the Safety and Efficacy of the Use of the Navigator Circulatory Management System (NAV-1)

This study has been completed.
Sponsor:
Collaborator:
Trident Clinical Research Pty Ltd
Information provided by:
Applied Physiology Pty Ltd
ClinicalTrials.gov Identifier:
NCT00468247
First received: April 30, 2007
Last updated: April 24, 2008
Last verified: April 2008
  Purpose

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.


Condition Intervention Phase
Critical Illness
Intensive Care
Device: Navigator
Other: Conventional care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:


Further study details as provided by Applied Physiology Pty Ltd:

Primary Outcome Measures:
  • Average distance to central point of the target cardiovascular zone while connected to the device [ Time Frame: Time connected to Navigator device ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage time in the target cardiovascular zone while connected to device [ Time Frame: Time connected to Navigator device ] [ Designated as safety issue: No ]
  • Clinically significant AF while connected to device [ Time Frame: Time connected to Navigator device ] [ Designated as safety issue: No ]
  • Multiple organ function (SOFA score) [ Time Frame: From connection to Navigator device to hospital discharge ] [ Designated as safety issue: Yes ]
  • Device-related adverse events and device failures [ Time Frame: Time connected to Navigator device ] [ Designated as safety issue: Yes ]

Enrollment: 112
Study Start Date: March 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Device , Navigator used for guiding haemodynamic care
Device: Navigator
Navigator circulatory mgt system
Placebo Comparator: 2
Conventional care
Other: Conventional care
Conventional haemodynamic care

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468247

Locations
Australia, New South Wales
Westmead Private Hospital
Sydney, New South Wales, Australia, 2145
Westmead Public Hospital
Sydney, New South Wales, Australia, 2145
St George Public Hospital
Sydney, New South Wales, Australia, 2217
St Vincent's Public Hospital
Sydney, New South Wales, Australia, 2010
Royal North Shore Hospital
Sydney, New South Wales, Australia, 2065
Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3181
Monash Medical Centre
Melbourne, Victoria, Australia, 3168
Sponsors and Collaborators
Applied Physiology Pty Ltd
Trident Clinical Research Pty Ltd
Investigators
Principal Investigator: Yugan Mudaliar, PhD Western Sydney Area Health Service
Study Director: Geoff Parkin, PhD Monash Medical Centre
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vickie Edwards, Applied Physiology Pty Ltd
ClinicalTrials.gov Identifier: NCT00468247     History of Changes
Other Study ID Numbers: AP2006-01
Study First Received: April 30, 2007
Last Updated: April 24, 2008
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Applied Physiology Pty Ltd:
mean systemic pressure
fluid therapy
closed loop control
circulation modelling

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014