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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05224245




Registration number
NCT05224245
Ethics application status
Date submitted
4/01/2022
Date registered
4/02/2022
Date last updated
15/06/2023

Titles & IDs
Public title
ACURATE Prime XL Human Feasibility Study
Scientific title
A Study to Evaluate the Feasibility and Safety of the ACURATE Prime™ XL Aortic Valve System in Patients Indicated for TAVI: ACURATE Prime XL Human Feasibility Study
Secondary ID [1] 0 0
S2458
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Stenosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - ACURATE Prime XL Transfemoral Aortic Valve System

Experimental: Single arm: ACURATE Prime XL Transfemoral Aortic Valve System - Subjects who provide written informed consent, meet all eligibility criteria, and are approved by the Case Review Committee (CRC) will be implanted with ACURATE Prime XL Transfemoral Aortic Valve using iSLEEVE, ACURATE Prime XL Delivery System and ACURATE Prime XL Loading kit


Treatment: Devices: ACURATE Prime XL Transfemoral Aortic Valve System
ACURATE Prime™ Transfemoral Aortic Valve system: Support frame made of nitinol, supra-annular processed tri-leaflet porcine pericardial valve and an outer skirt to limit paravalvular regurgitation (manufactured by Boston Scientific Corporation, Marlborough, MA, USA).
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with Device Success
Timepoint [1] 0 0
Through discharge or 7 days post procedure
Primary outcome [2] 0 0
Number of participants who died or experienced a stroke
Timepoint [2] 0 0
Through 30 Days post procedure

Eligibility
Key inclusion criteria
* IC1. Subject has documented severe symptomatic native aortic stenosis defined as follows: aortic valve area (AVA) =1.0 cm2 (or AVA index =0.6 cm2/m2) AND a mean pressure gradient =40 mmHg, OR maximal aortic valve velocity =4.0 m/s, OR Doppler velocity index =0.25 as measured by echocardiography and/or invasive hemodynamics. Note: In cases of low flow, low gradient aortic stenosis with left ventricular dysfunction (ejection fraction <50%), dobutamine can be used to assess the grade of aortic stenosis (maximum dobutamine dose of 20 mcg/kg/min recommended); the subject may be included in the study if echocardiographic criteria are met with this augmentation.
* IC2. Subject has a documented aortic annulus diameter of =26.5 mm and =29 mm based on the center's assessment of pre-procedure diagnostic imaging (and confirmed by the Case Review Committee [CRC]).
* IC3. For subjects with symptomatic aortic valve stenosis per IC1 definition above, functional status is NYHA Functional Class = II.
* IC4. Heart team (composition per local standards, but at a minimum must include an experienced cardiac surgeon) agrees that the subject is indicated for TAVI, is likely to benefit from prosthetic valve implantation, and TAVI is appropriate.
* IC5. Subject (or legal representative) understands the study requirements and the treatment procedures and provides written informed consent.
* IC6. Subject, family member, and/or legal representative agree(s) and subject is capable of returning to the study hospital for all required scheduled follow up visits.
* IC7. Subject is expected to be able to take the protocol-required adjunctive pharmacologic therapy.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* EC1. Subject has a unicuspid or bicuspid aortic valve.
* EC2. Subject has had an acute myocardial infarction within 30 days prior to the index procedure (defined as Q-wave MI or non-Q-wave MI with total CK elevation = twice normal in the presence of CK MB elevation and/or troponin elevation).
* EC3.Subject has had a cerebrovascular accident or transient ischemic attack clinically confirmed by a neurologist or neuroimaging within the past 6 months prior to study enrollment.
* EC4.Subject has eGFR < 20 mL/min (based on hospital preferred method) but is not on renal replacement therapy.
* EC5. Subject has a pre-existing prosthetic aortic or mitral valve.
* EC6. Subject has severe (4+) aortic, tricuspid, or mitral regurgitation.
* EC7. Subject has moderate or severe mitral stenosis (mitral valve area =1.5 cm2 and diastolic pressure half-time =150 ms, Stage C or D).
* EC8. Subject has a need for emergency surgery for any reason.
* EC9. Subject has a history of endocarditis within 6 months of index procedure or evidence of an active systemic infection or sepsis.
* EC10. Subject has echocardiographic evidence of new intra-cardiac vegetation or intraventricular or paravalvular thrombus requiring intervention.
* EC11. Subject has platelet count <50,000 cells/mm3 or >700,000 cells/mm3, or white blood cell count <1,000 cells/mm3.
* EC12. Subject has had a gastrointestinal bleed requiring hospitalization or transfusion within the past 3 months or has other clinically significant bleeding diathesis or coagulopathy that would preclude treatment with required antiplatelet regimen or will refuse transfusions.
* EC13. Subject has known hypersensitivity to the following:

* Contrast agents that cannot be adequately pre-medicated, OR
* Protocol-required medications (aspirin, all P2Y12 inhibitors, heparin), OR
* Individual components of the investigational valve and/or delivery system (stainless steel, platinum, iridium, nickel, titanium, or polyethylene terephthalate [PET]).
* EC14. Subject has a life expectancy of less than 12 months due to non-cardiac, comorbid conditions based on the assessment of the investigator at the time of enrollment.
* EC15. Subject has hypertrophic cardiomyopathy.
* EC16. Subject has any therapeutic invasive cardiac or vascular procedure within 30 days prior to the index procedure (except for balloon aortic valvuloplasty, pacemaker implantation, or implantable cardioverter defibrillator implantation, which are allowed).
* EC17. Subject has untreated coronary artery disease, which in the opinion of the treating physician is clinically significant and requires revascularization.
* EC18. Subject has severe left ventricular dysfunction with ejection fraction <20%.
* EC19. Subject is in cardiogenic shock or has hemodynamic instability requiring inotropic support or mechanical support devices.
* EC20. Subject has arterial access that is not acceptable for the study device delivery system as defined in the Instructions For Use.
* EC21. Subject has either of the following:

* Severe vascular disease that would preclude safe access (e.g., aneurysm with thrombus that cannot be crossed safely; marked tortuosity; significant narrowing of the abdominal aorta; severe unfolding of the thoracic aorta; or thick, protruding, ulcerated atheroma in the aortic arch), OR
* Severe/eccentric calcification of the aortic annulus that would prevent safe implantation of the TAVI prosthesis.
* EC22. Subject has current problems with substance abuse (e.g., alcohol, etc.) that may interfere with the subject's participation in this study.
* EC23. Subject is participating in another investigational drug or device study that has not reached its primary endpoint or subject intends to participate in another investigational device clinical trial within 12 months after the index procedure.
* EC24. Subject has untreated conduction system disorder (e.g., Type II second degree atrioventricular block) that in the opinion of the treating physician is clinically significant and requires a pacemaker implantation. Enrollment is permissible after permanent pacemaker implantation.
* EC25. Subject has severe incapacitating dementia.

Study design
Purpose of the study
Other
Allocation to intervention
NA
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
NA
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
3/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/05/2023
Sample size
Target
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Robert Gooley, MBBS
Address 0 0
Monash Medical Centre
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05224245