Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000438358
Ethics application status
Approved
Date submitted
23/07/2008
Date registered
29/08/2008
Date last updated
25/11/2019
Date data sharing statement initially provided
25/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Baseline Results and Cost-effectiveness Study - VentrAssist left ventricular assist device
Scientific title
Evaluating the use of the VentrAssist left ventricular assist device (LVAD) in a population with end-stage heart failure with data comparable to published data from similar devices
Universal Trial Number (UTN)
Trial acronym
BRACE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End stage heart failure 3452 0
Condition category
Condition code
Cardiovascular 3610 3610 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The VentrAssist left ventricular assist device is an active implantable medical device used to bridge patients (maintain circulatory support) until a donor heart may be found, or may be implanted as destination therapy (for the remainder of the participants life). Patients will be followed up at clinic visits until transplant, explant, death or 24 months post implant. Each visit will take approxiamtely 30-60 minutes to complete.
Intervention code [1] 3180 0
Not applicable
Comparator / control treatment
Published data from other left ventricual assist devices. There is no control group for this study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4504 0
Actuarial survival for VentrAssist LVAD patients, where patients are censored from the actuarial survival curve on LVAD removal (for heart transplantation or native heart recovery
Timepoint [1] 4504 0
24 months post device implant
Secondary outcome [1] 7616 0
Safety (serious adverse events). Serious adverse events will be categorised using the Interagency Registry for Mechanical Assisted Circulatory Support (INTERMACS) definitions.
Timepoint [1] 7616 0
24 months post device implant
Secondary outcome [2] 7617 0
New York Heart Association functional status used to categorize heart failure.
Timepoint [2] 7617 0
24 months post device implant
Secondary outcome [3] 7618 0
Quality of life questionnaire - EUROQOL and SF-36
Timepoint [3] 7618 0
24 months post device implant
Secondary outcome [4] 7619 0
Economic data - examine the number and duration of hospital addmissions, procedures and medication use as a surrogate measure of cost.
Timepoint [4] 7619 0
24 months post device implant

Eligibility
Key inclusion criteria
Body surface area equal to or greater than 1.2 meters squared; need for mechanical circulatory support; ability to provide informed consent; ability to perform ongoing functions of device management; age greater than or equal to 18 years of age (French sites only)
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Stroke in the 90 days prior to enrolment or cerebrovascular disease with significant carotid stenosis; chronic renal failure; significant hepatic disease; significant pulmonary disease; clinical signs of systemic infection; fixed right ventricular failure; coagulation systemic disorders; mechanical prosthetic aortic valve; echocardiographic evidence of moderate/sever aortic/tricuspid valve insufficiency; cachexia or clinical signs of severe malnourishment; technically challenging cardiac disease e.g. hypertrophic or restrictive cardiomyopathy; previous heart transplant, cardiomyoplasty or passive restraint device insertion; contraindication to the administration of anticoagulant or antiaggregation agents; psychiatric/psychological disorders likely to impair with protocol compliance or device management; pregnancy

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/06/2006
Actual
16/08/2006
Date of last participant enrolment
Anticipated
Actual
30/06/2009
Date of last data collection
Anticipated
Actual
30/06/2009
Sample size
Target
75
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment outside Australia
Country [1] 1051 0
United Kingdom
State/province [1] 1051 0
Country [2] 1052 0
France
State/province [2] 1052 0
Country [3] 1053 0
Germany
State/province [3] 1053 0
Country [4] 1054 0
Sweden
State/province [4] 1054 0
Country [5] 1055 0
Norway
State/province [5] 1055 0

Funding & Sponsors
Funding source category [1] 3633 0
Commercial sector/Industry
Name [1] 3633 0
Ventracor Limited
Country [1] 3633 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Ventracor Limited
Address
126 Greville Street,
Chatswood, NSW, 2067
Country
Australia
Secondary sponsor category [1] 3267 0
None
Name [1] 3267 0
Address [1] 3267 0
Country [1] 3267 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5688 0
Huntingdon Research Ethics Committee
Ethics committee address [1] 5688 0
Ethics committee country [1] 5688 0
United Kingdom
Date submitted for ethics approval [1] 5688 0
03/07/2006
Approval date [1] 5688 0
16/08/2006
Ethics approval number [1] 5688 0
06/Q0104/77

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

Contacts
Principal investigator
Name 28774 0
Prof Donald Esmore
Address 28774 0
55 Commercial Road, Melbourne, VIC, 3004
Country 28774 0
Australia
Phone 28774 0
+61 3 9076 2000
Fax 28774 0
Email 28774 0
[email protected]
Contact person for public queries
Name 11931 0
Terry McCarthy
Address 11931 0
Cereslaan 34
5384 VT
Heesch
Country 11931 0
Netherlands
Phone 11931 0
+31 412 487 140
Fax 11931 0
Email 11931 0
[email protected]
Contact person for scientific queries
Name 2859 0
John Woodard
Address 2859 0
126 Greville Street,
Chatswood, NSW, 2067
Country 2859 0
Australia
Phone 2859 0
+61 2 9406 3102
Fax 2859 0
Email 2859 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.