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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
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
Secondary ID [1] 0 0
2011-14
Universal Trial Number (UTN)
Trial acronym
SOLACE-AU
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe, Symptomatic Aortic Stenosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
VARC-2 Composite Safety Endpoint - 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.
Timepoint [1] 0 0
30 days
Secondary outcome [1] 0 0
All Cause Mortality
Timepoint [1] 0 0
30 days
Secondary outcome [2] 0 0
All Cause Mortality
Timepoint [2] 0 0
12 months

Eligibility
Key inclusion criteria
- Age > 70 years

- STS Score > 4

- Heart team agrees on eligibility including assessment that TAVR or AVR is appropriate
Minimum age
70 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
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)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Macquarie Unversity Hospital - Macquarie Park
Recruitment hospital [3] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [4] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [5] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [6] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [7] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [8] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [9] 0 0
St Vincent's Hospital - MELBOURNE - Melbourne
Recruitment hospital [10] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [11] 0 0
Royal Perth Hospital/Fiona Stanley Hospital - Perth
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
2065 - St. Leonards
Recruitment postcode(s) [5] 0 0
4032 - Chermside
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
5042 - Bedford Park
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment postcode(s) [9] 0 0
3065 - Melbourne
Recruitment postcode(s) [10] 0 0
3050 - Parkville
Recruitment postcode(s) [11] 0 0
6000 - Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Edwards Lifesciences
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Pacific Clinical Research Group
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT01675596
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Dr. Owen Christopher Raffel
Address 0 0
The Prince Charles Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications