Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618001180202
Ethics application status
Approved
Date submitted
18/06/2018
Date registered
17/07/2018
Date last updated
10/12/2020
Date data sharing statement initially provided
10/12/2020
Date results information initially provided
10/12/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Balloon aortic valvuloplasty versus surgical aortic valvuloplasty for congenital aortic valve stenosis.
Scientific title
Non- randomized comparison mortality in patients receiving balloon aortic valvuloplasty versus surgical aortic valvuloplasty for congenital aortic valve stenosis, using propensity score matching.
Secondary ID [1] 295227 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congenital aortic valve stenosis 308383 0
Condition category
Condition code
Cardiovascular 307376 307376 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Data from children with congenital heart disease who have undergone balloon aortic valvuloplasty (Lady Cilento Children's Hospital, Royal Children's Hospital) between January 1st 2002 and December 31st 2016. Endpoints will be examined at 30 days (early outcomes) and 12 months (long-term outcomes) following intervention.
Intervention code [1] 301563 0
Not applicable
Comparator / control treatment
Data from children who have undergone either surgical aortic valvuloplasty (The Royal Children's Hospital) and balloon aortic valvuloplasty (Lady Cilento Children's Hospital) between 2002 and 2016.
Control group
Historical

Outcomes
Primary outcome [1] 306347 0
Mortality as documented in medical records
Timepoint [1] 306347 0
1 year post intervention (balloon aortic valvuloplasty or surgival aortic valvuloplasty)
Secondary outcome [1] 348240 0
Re intervention to treat aortic stenosis at 1 year as documented in medical records.
Timepoint [1] 348240 0
1 year post intervention (balloon aortic valvuloplasty or surgival aortic valvuloplasty)
Secondary outcome [2] 348241 0
Residual valvular regurgitation as recorded in medical records
Timepoint [2] 348241 0
1 year post intervention (balloon aortic valvuloplasty or surgival aortic valvuloplasty)
Secondary outcome [3] 348242 0
Valve replacement as recorded in medical records
Timepoint [3] 348242 0
1 year post intervention (balloon aortic valvuloplasty or surgival aortic valvuloplasty)
Secondary outcome [4] 348299 0
Residual aortic stenosis as recorded in medical records
Timepoint [4] 348299 0
1 year post intervention (balloon aortic valvuloplasty or surgival aortic valvuloplasty)

Eligibility
Key inclusion criteria
Patients who underwent balloon aortic valvuloplasty or surgical aortic valvuloplasty for congenital aortic valve stenosis between 2002 to 2016
Minimum age
No limit
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with congenital AS who underwent univentricular repair, homograft valve replacement and Ross procedure, as their initial procedure.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Data will be presented as mean +/- SD, median (range) or frequency (% of appropriate cohort). Demographic, diagnostic, procedural and early outcomes (up to 30 days after surgery) and long term outcomes between two groups will be compared using appropriate parametric and non-parametric tests for normally and non-normally distributed variables respectively.
Time-related outcomes, both primary and secondary, and survival will be analyzed
using the Kaplan Meier method. Kaplan Meier curves for both groups will be compared using the log-rank test.
Propensity score matching will be used to derive matched pairs of patients using the following criteria. The analysis will be repeated in the propensity score matched pairs.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
22/10/2017
Date of last participant enrolment
Anticipated
Actual
19/06/2018
Date of last data collection
Anticipated
31/07/2018
Actual
31/12/2018
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 11174 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment hospital [2] 11175 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 23001 0
4101 - South Brisbane
Recruitment postcode(s) [2] 23002 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 299817 0
Hospital
Name [1] 299817 0
Lady Cilento Children's Hospital
Country [1] 299817 0
Australia
Funding source category [2] 299843 0
Hospital
Name [2] 299843 0
The Royal Children's Hospital
Country [2] 299843 0
Australia
Primary sponsor type
Other
Name
Queensland Paediatric Cardiac Services
Address
Level 7 Clinical Directorate
Lady Cilento Children's Hospital
501 Stanley Street
South Brisbane QLD 4101
Country
Australia
Secondary sponsor category [1] 299170 0
None
Name [1] 299170 0
Nil
Address [1] 299170 0
NA
Country [1] 299170 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300696 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee [ED00175]
Ethics committee address [1] 300696 0
Level 7, Centre for Children's Health Research
Lady Cilento Children's Hospital
501 Stanley Street
South Brisbane QLD 4101
Ethics committee country [1] 300696 0
Australia
Date submitted for ethics approval [1] 300696 0
12/10/2017
Approval date [1] 300696 0
22/10/2017
Ethics approval number [1] 300696 0
HREC/17/QRCH/249

Summary
Brief summary
Congenital aortic stenosis is a lifelong disease often requiring multiple interventions. Valvuloplasty refers to the procedure by which the valve obstruction is relieved by either incising the valve during a surgical procedure or utilising balloon to stretch the valve during an interventional cardiology procedure. We are seeking to determine the early and late outcomes of surgical or balloon aortic valvuloplasty and whether the technique use, influences the long term risk of re-intervention, other morbidities, or death.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84510 0
A/Prof Nelson Alphonso
Address 84510 0
Level 7, Clinical Directorate
Lady Cilento Children's Hospital
501 Stanley Street
South Brisbane QLD 4101
Country 84510 0
Australia
Phone 84510 0
+61 7 3068 5775
Fax 84510 0
Email 84510 0
[email protected]
Contact person for public queries
Name 84511 0
Mrs Jessica Suna
Address 84511 0
Level 4, Centre for Children's Health Research
Lady Cilento Children's Hospital
501 Stanley Street
South Brisbane QLD 4101
Country 84511 0
Australia
Phone 84511 0
+61 7 3069 7256
Fax 84511 0
Email 84511 0
[email protected]
Contact person for scientific queries
Name 84512 0
A/Prof Nelson Alphonso
Address 84512 0
Level 7, Clinical Directorate
Lady Cilento Children's Hospital
501 Stanley Street
South Brisbane QLD 4101
Country 84512 0
Australia
Phone 84512 0
+61 7 3068 5775
Fax 84512 0
Email 84512 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.