Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000100594
Ethics application status
Approved
Date submitted
19/12/2023
Date registered
6/02/2024
Date last updated
6/06/2024
Date data sharing statement initially provided
6/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Edwards 12F Sheath Feasibility Study
Scientific title
Prospective, single arm, multicentre, feasibility study to demonstrate the safety and functionality of the Edwards 12F Sheath Introducer Set in conjunction with the SAPIEN X4 Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS) (Protocol number: 2023-06)
Secondary ID [1] 310437 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic stenosis 331237 0
Condition category
Condition code
Cardiovascular 327996 327996 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will evaluate the use of TAVR (Transcatheter Aortic Valve Replacement), which is a minimally invasive procedure designed to replace the aortic valve inside the heart. The devices that will be used include the Edwards 12F Sheath Introducer Set, a hollow, flexible tube used to facilitate insertion of devices into the vasculature, and the SAPIEN X4 Transcatheter Heart Valve, an artificial heart valve that is made to replace the diseased aortic heart valve. The TAVR procedure will be performed by an experienced heart surgeon and/or cardiologist in the hospital under local or general anaesthesia. The SAPIEN X4 valve will remain in the body following the procedure but the 12F Sheath is removed at the end of the procedure.
Intervention code [1] 326849 0
Treatment: Devices
Comparator / control treatment
No Control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335851 0
Vascular and access-related complications (assessed by review of medical records and using VARC-3 definitions), e.g., haematoma, embolization, nerve injury .
Timepoint [1] 335851 0
30 days
Secondary outcome [1] 425905 0
This is a composite secondary outcome. Successful access, delivery of the device, and retrieval of the delivery system (assessed by review of medical records).
Timepoint [1] 425905 0
End of the procedure.

Eligibility
Key inclusion criteria
1. Severe, calcific AS
2. Native aortic annulus size suitable for SAPIEN X4 THV
3. NYHA functional class greater than or equal to II
4. The subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Anatomical characteristics that would preclude safe femoral placement of the introducer sheath or safe passage of the delivery system
2. Aortic valve is unicuspid, non-calcified, or aortic valve is bicuspid with aneurysmal ascending aorta greater than 4.5 cm and/or severe raphe/leaflet calcification
3. Pre-existing mechanical or bioprosthetic valve in any position
4. Severe aortic regurgitation (greater than 3plus)
5. Severe mitral regurgitation (greater than 3olus) or greater than or equal to moderate mitral stenosis
6. Need for mitral, tricuspid, or pulmonic valve intervention within the next 12 months
7. Left ventricular ejection fraction less than 20%
8. Cardiac imaging evidence of intracardiac mass, thrombus, or vegetation
9. Left ventricular outflow tract calcification that would increase the risk of annular rupture or significant paravalvular leak (PVL) after THV implantation
10. Increased risk of coronary artery obstruction after THV implantation
11. Myocardial infarction within 30 days prior to the study procedure
12. Hypertrophic cardiomyopathy with subvalvular obstruction
13. Subjects with planned concomitant ablation for atrial fibrillation
14. Complex coronary artery disease (CAD) that cannot be optimally treated by percutaneous coronary intervention (PCI)
15. Any surgical or transcatheter procedure within 30 days prior to the study procedure (unless part of planned strategy for treatment of CAD). Implantation of a permanent pacemaker or implantable cardioverter defibrillator (ICD) is not considered an exclusion.
16. Any planned surgical or transcatheter intervention to be performed within 30 days following the study procedure (unless part of planned strategy for treatment of CAD)
17. Endocarditis within 180 days prior to the study procedure
18. Stroke, transient ischemic attack or neurological signs and symptoms attributed to carotid or vertebrobasilar disease within 90 days prior to the study procedure
19. Hemodynamic or respiratory instability requiring inotropic or mechanical support within 30 days prior to the study procedure
20. Renal insufficiency and/or renal replacement therapy
21. Leukopenia, anaemia, thrombocytopenia
22. Inability to tolerate or condition precluding treatment with antithrombotic therapy
23. Hypercoagulable state or other condition that increases risk of thrombosis
24. Absolute contraindications or allergy to iodinated contrast that cannot be adequately treated with premedication
25. Subject refuses blood products
26. BMI greater than 50 kg/m2
27. Estimated life expectancy less than 24 months
28. Female who is pregnant or lactating
29. Active SARS-CoV-2 infection
30. Participating in another investigational drug or device study that has not reached its primary endpoint
31. Subject considered to be part of a vulnerable population

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/02/2024
Actual
21/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment outside Australia
Country [1] 25723 0
New Zealand
State/province [1] 25723 0

Funding & Sponsors
Funding source category [1] 314643 0
Commercial sector/Industry
Name [1] 314643 0
Edwards Lifesciences
Country [1] 314643 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Edwards Lifesciences LLC
Address
One Edwards Way Irvine, CA 92614
Country
United States of America
Secondary sponsor category [1] 316623 0
None
Name [1] 316623 0
Address [1] 316623 0
Country [1] 316623 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313664 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 313664 0
https://www.rah.sa.gov.au/research/for-researchers/central-adelaide-local-health-network-human-research-ethics-committee
Ethics committee country [1] 313664 0
Australia
Date submitted for ethics approval [1] 313664 0
11/09/2023
Approval date [1] 313664 0
10/11/2023
Ethics approval number [1] 313664 0
2023/HRE00224
Ethics committee name [2] 313678 0
Northern B Health and Disability Ethics Committee
Ethics committee address [2] 313678 0
https://ethics.health.govt.nz/about/northern-b-health-and-disability-ethics-committee/
Ethics committee country [2] 313678 0
New Zealand
Date submitted for ethics approval [2] 313678 0
28/09/2023
Approval date [2] 313678 0
15/12/2023
Ethics approval number [2] 313678 0
2023 FULL 18663
Ethics committee name [3] 315469 0
UnitingCare Health Human Research Ethics Committee
Ethics committee address [3] 315469 0
http://unitingcarehealth.com.au/research-and-education/unitingcare-health-human-research-ethics-committee
Ethics committee country [3] 315469 0
Australia
Date submitted for ethics approval [3] 315469 0
24/10/2023
Approval date [3] 315469 0
05/04/2024
Ethics approval number [3] 315469 0
202327

Summary
Brief summary
The objective of this study is to demonstrate the safety and functionality of the Edwards 12F Sheath Introducer Set in conjunction with the Edwards SAPIEN X4 THV in subjects with symptomatic, severe, calcific AS.
This is a prospective, single arm, multicentre, feasibility study that will include up to 30 subjects who have the 12F Sheath inserted at up to 5 sites in Australia and New Zealand. Subjects will be assessed at screening, procedure, post-procedure, discharge, and 30 days.
Expected enrolment duration is approximately 6 months, resulting in a total study duration of approximately 9 months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128934 0
Dr Joe Montarello
Address 128934 0
Royal Adelaide Hospital North Terrace, Adelaide, South Australia 5000
Country 128934 0
Australia
Phone 128934 0
+61 8 7074 1796
Fax 128934 0
Email 128934 0
Joe.Montarello@sa.gov.au
Contact person for public queries
Name 128935 0
Mrs Christy Thiel
Address 128935 0
Edwards Lifesciences Pty Ltd 2/40 Talavera Road Macquarie Park NSW 2113
Country 128935 0
Australia
Phone 128935 0
+61 428 142 491
Fax 128935 0
Email 128935 0
christy_thiel@edwards.com
Contact person for scientific queries
Name 128936 0
Mrs Christy Thiel
Address 128936 0
Edwards Lifesciences Pty Ltd 2/40 Talavera Road Macquarie Park NSW 2113
Country 128936 0
Australia
Phone 128936 0
+61 428 142 491
Fax 128936 0
Email 128936 0
christy_thiel@edwards.com

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.