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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/NCT01675596
Registration number
NCT01675596
Ethics application status
Date submitted
28/08/2012
Date registered
30/08/2012
Date last updated
16/04/2019
Titles & IDs
Public title
The SOLACE-AU Clinical Trial
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Scientific title
A Multicentre, Non-Randomised Controlled Study of the Safety, Performance, Quality of Life and Cost Effectiveness Outcomes of the Edwards SAPIEN XT™ Transcatheter Heart Valve in an Australian Population
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Secondary ID [1]
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2011-14
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Universal Trial Number (UTN)
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Trial acronym
SOLACE-AU
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Severe, Symptomatic Aortic Stenosis
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
Experimental: Test - SAPIEN XT™ valve with the NovaFlex and NovaFlex+ delivery systems.
Treatment: Devices: TAVR Implantation of the Transcatheter Aortic Valve Prosthesis
Operable subjects
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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VARC-2 Composite Safety Endpoint
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Assessment method [1]
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The primary endpoint is a VARC-2 Composite. It comprises of
All cause mortality
All stroke
Life-threatening bleeding
Acute kidney injury - Stage 3 (including renal replacement therapy)
Coronary artery obstruction requiring intervention
Major vascular complications
Valve related dysfunction (requiring repeat procedure)
A composite endpoint is an endpoint that is a combination of multiple components.
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Timepoint [1]
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30 days
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Secondary outcome [1]
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All Cause Mortality
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Assessment method [1]
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Timepoint [1]
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30 days
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Secondary outcome [2]
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All Cause Mortality
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Assessment method [2]
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Timepoint [2]
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12 months
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Eligibility
Key inclusion criteria
- Age > 70 years
- STS Score > 4
- Heart team agrees on eligibility including assessment that TAVR or AVR is appropriate
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Minimum age
70
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Age <70 years
- Evidence of an acute myocardial infarction = 30 days
- Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is
non-calcified
- Stroke or transient ischemic attack (TIA) within 6 months of the procedure
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
8/08/2018
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Sample size
Target
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Accrual to date
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Final
199
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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Macquarie Unversity Hospital - Macquarie Park
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Recruitment hospital [3]
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Prince of Wales Hospital - Randwick
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Recruitment hospital [4]
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Royal North Shore Hospital - St. Leonards
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Recruitment hospital [5]
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The Prince Charles Hospital - Chermside
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Recruitment hospital [6]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [7]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [8]
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The Alfred Hospital - Melbourne
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Recruitment hospital [9]
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St Vincent's Hospital - MELBOURNE - Melbourne
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Recruitment hospital [10]
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Royal Melbourne Hospital - Parkville
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Recruitment hospital [11]
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Royal Perth Hospital/Fiona Stanley Hospital - Perth
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2109 - Macquarie Park
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Recruitment postcode(s) [3]
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2031 - Randwick
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Recruitment postcode(s) [4]
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2065 - St. Leonards
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Recruitment postcode(s) [5]
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4032 - Chermside
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Recruitment postcode(s) [6]
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5000 - Adelaide
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Recruitment postcode(s) [7]
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5042 - Bedford Park
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Recruitment postcode(s) [8]
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3004 - Melbourne
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Recruitment postcode(s) [9]
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3065 - Melbourne
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Recruitment postcode(s) [10]
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3050 - Parkville
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Recruitment postcode(s) [11]
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6000 - Perth
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Edwards Lifesciences
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Pacific Clinical Research Group
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The objective of the study is to observe the safety, efficacy and cost effectiveness of the
Edwards SAPIEN XT valve for the treatment of severe calcific degenerative aortic stenosis.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01675596
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr. Owen Christopher Raffel
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Address
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The Prince Charles Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01675596
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