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Trial registered on ANZCTR


Registration number
ACTRN12611001026910
Ethics application status
Approved
Date submitted
16/09/2011
Date registered
27/09/2011
Date last updated
27/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
SOURCE ANZ - An observational study using registry data to assess safety and efficacy outcomes data in patients with diagnosed Aortic Valve Stenosis who may be eligible for replacing the aortic heart valve without the need for open heart surgery
Scientific title
Edwards SAPIEN Transcatheter Heart Valve Australian and New Zealand SOURCE Registry: A multi-centre Observational Registry of Percutaneous Aortic Valve Replacement (PAVR) using the Edwards SAPIEN Transcatheter Heart Valve to collect the safety and efficacy outcomes data.
Secondary ID [1] 263037 0
SOURCE Registry # 2008-01
Universal Trial Number (UTN)
Trial acronym
SOURCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe Aortic Stenosis 270765 0
Condition category
Condition code
Cardiovascular 270947 270947 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients with severe Aortic Stenosis may be eligible for the insertion of a biological heart valve implanted percutaneously via the transfemoral or transapical route then balloon expanded once in the aortic valve position.
The SOURCE registry is a database documenting patient outcomes at 30 days and 12 months post procedure.
The data extracted measures procedure success and quality of life improvement. Also measured are the major complications associated with the procedure and device.
Intervention code [1] 269381 0
Not applicable
Comparator / control treatment
No treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279620 0
Safety and efficacy measured by procedural success at 30 days
Timepoint [1] 279620 0
30 days
Secondary outcome [1] 294044 0
Collect the safety and efficacy outcomes data of the patients who received the Edwards SAPIEN Valve for the treatment of calcific dengenerative aortic stenosis.
Timepoint [1] 294044 0
Hospital discharge
Secondary outcome [2] 294149 0
Collect the safety and efficacy outcomes data of the patients who received the Edwards SAPIEN Valve for the treatment of calcific dengenerative aortic stenosis
Timepoint [2] 294149 0
12 months

Eligibility
Key inclusion criteria
Key inclusion critieria –
1. Aortic valve area <0.8 cm2
2. Patients with symptomatic, severe calcific degenerative aortic stenosis requiring AVR, and considered to have high risk of operative mortality or is ‘non-operable’.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Key Exclusion criteria –
1. Patients with non-valvular, non-calcific acquired or congenital aortic stenosis, with unicuspid or bicuspid aortic valve
2. Patients unsuitable for AVR via transfemoral or transapical approach

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4486 0
4064
Recruitment postcode(s) [2] 4489 0
2010
Recruitment postcode(s) [3] 4490 0
2305
Recruitment postcode(s) [4] 4491 0
2031
Recruitment postcode(s) [5] 4492 0
2065
Recruitment postcode(s) [6] 4493 0
5042
Recruitment postcode(s) [7] 4494 0
6000
Recruitment outside Australia
Country [1] 3840 0
New Zealand
State/province [1] 3840 0
Hamilton

Funding & Sponsors
Funding source category [1] 269840 0
Hospital
Name [1] 269840 0
The Prince Charles Hospital
Address [1] 269840 0
Rode Road
Chermside QLD 4064
Country [1] 269840 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Edwards Lifesciences Pty Ltd
Address
8/167 Prospect Highway
Seven Hills NSW 2147
Country
Australia
Secondary sponsor category [1] 268871 0
None
Name [1] 268871 0
Address [1] 268871 0
Country [1] 268871 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271813 0
The Prince Charles Hospital
Ethics committee address [1] 271813 0
Rode Road
Chermside QLD 4064
Ethics committee country [1] 271813 0
Australia
Date submitted for ethics approval [1] 271813 0
23/10/2009
Approval date [1] 271813 0
11/02/2010
Ethics approval number [1] 271813 0
HREC/09/QCPH/177
Ethics committee name [2] 271819 0
St Vincent's Hospital Sydney Human Research and Ethics Committee
Ethics committee address [2] 271819 0
390 Victoria Street
Darlinghurst NSW 2010
Ethics committee country [2] 271819 0
Australia
Date submitted for ethics approval [2] 271819 0
Approval date [2] 271819 0
21/05/2009
Ethics approval number [2] 271819 0
HREC/08/SVH/178
Ethics committee name [3] 271820 0
Hunter Area Health Service Human Research and Ethics Committee
Ethics committee address [3] 271820 0
Lookout Road
New Lambton NSW 2305
Ethics committee country [3] 271820 0
Australia
Date submitted for ethics approval [3] 271820 0
Approval date [3] 271820 0
23/04/2010
Ethics approval number [3] 271820 0
HREC/09/SVH/178
Ethics committee name [4] 271821 0
South Eastern Sydney Health Service Human Research and Ethics Committee
Ethics committee address [4] 271821 0
Barker Street
Randwick NSW 2031
Ethics committee country [4] 271821 0
Australia
Date submitted for ethics approval [4] 271821 0
Approval date [4] 271821 0
09/06/2010
Ethics approval number [4] 271821 0
08/SVH/178
Ethics committee name [5] 271822 0
Northern Sydney Area Health Service Royal North Shore Hospital
Ethics committee address [5] 271822 0
Pacific Highway
St Leonards NSW 2065
Ethics committee country [5] 271822 0
Australia
Date submitted for ethics approval [5] 271822 0
Approval date [5] 271822 0
03/05/2010
Ethics approval number [5] 271822 0
08/SVH/178
Ethics committee name [6] 271823 0
Flinders Clinical Research Ethics Committee
Ethics committee address [6] 271823 0
Flinders Medical Centre
Flinders Drive
Bedford Park SA 5042
Ethics committee country [6] 271823 0
Australia
Date submitted for ethics approval [6] 271823 0
Approval date [6] 271823 0
11/12/2008
Ethics approval number [6] 271823 0
1/08/0258
Ethics committee name [7] 271837 0
Royal Perth Hospital Human Research and Ethics Committee
Ethics committee address [7] 271837 0
Wellington Street
Perth WA 6000
Ethics committee country [7] 271837 0
Australia
Date submitted for ethics approval [7] 271837 0
Approval date [7] 271837 0
07/04/2009
Ethics approval number [7] 271837 0
TGA 2OO9.01

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

Contacts
Principal investigator
Name 33152 0
Address 33152 0
Country 33152 0
Phone 33152 0
Fax 33152 0
Email 33152 0
Contact person for public queries
Name 16399 0
Meryl Musson
Address 16399 0
8/167 Prospect Highway
Seven Hills NSW 2147
Country 16399 0
Australia
Phone 16399 0
+61 2 8811 2604
Fax 16399 0
+61 2 8811 2614
Email 16399 0
meryl_musson@edwards.com
Contact person for scientific queries
Name 7327 0
Meryl Musson
Address 7327 0
8/167 Prospect Highway
Seven Hills NSW 2147
Country 7327 0
Australia
Phone 7327 0
+61 2 8811 2604
Fax 7327 0
+61 2 8811 2614
Email 7327 0
meryl_musson@edwards.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary