CClinicalTrials.gg
Sign In
CompletedNCT05224245Updated Jun 15, 2023

ACURATE Prime XL Human Feasibility Study

An interventional study of ACURATE Prime XL Transfemoral Aortic Valve System in Aortic Stenosis, sponsored by Boston Scientific Corporation. Completed at 3 sites in Australia. Per ClinicalTrials.gov, last updated 2023-06-15.

Sponsored by Boston Scientific Corporation · Not applicable, Interventional, and Device feasibility

Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Sex
All
01

Study summary

To evaluate feasibility and safety of the ACURATE Prime™ XL Transfemoral Aortic Valve System for transcatheter aortic valve implantation (TAVI) in subjects with severe native aortic stenosis who are indicated for TAVI.

Read the detailed description

The ACURATE Prime XL Human Feasibility Study (ACURATE Prime XL HFS) is a prospective, multicenter, open-label, single-arm study designed to evaluate feasibility and safety of the ACURATE Prime XL Transfemoral Aortic Valve System for TAVI in subjects who have severe native aortic stenosis and are indicated for TAVI.

Subjects who provide written informed consent, meet all eligibility criteria, and are approved by the Case Review Committee (CRC) are considered enrolled when an attempt is made to insert the iSLEEVE Introducer into the subject's femoral artery. There will be up to 20 subjects enrolled at up to 6 centers in Australia and Europe.

All subjects implanted with a study valve will be assessed at baseline, peri- and post-procedure, at discharge or 7 days post index procedure (whichever comes first), 30 days, 6 months, and 1 year. Subjects who are enrolled but not implanted with a study valve at the time of the procedure will be followed for safety through 30 days.

02

Conditions studied

  • Aortic Stenosis

Browse trials for

Keywords

  • ACURATE Prime™ XL Aortic Valve System
03

In context

Aortic Valve Stenosis

985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.

This study's enrollment of 13 is below the median of 120 across 525 interventional studies indexed under Aortic Valve Stenosis.

Browse Aortic Valve Stenosis studies →

Lead sponsor

Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.

Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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.

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • 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

    Device: ACURATE Prime XL Transfemoral Aortic Valve System

Interventions

  • DeviceACURATE 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).

06

What researchers measure

Primary outcomes

  1. Number of participants with Device Success

    Absence of procedural mortality, AND Correct positioning of a single valve into the proper anatomical location, AND Intended performance of the study device (indexed effective orifice area \[iEOA\] \>0.85 cm2/m2 for BMI \<30 kg/m2 and iEOA \>0.70 cm2/m2 for BMI ≥30 kg/m2 plus either a mean aortic valve gradient \<20 mmHg or a peak velocity \<3m/sec, and no moderate or severe prosthetic valve aortic regurgitation) as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory.

    Time frame: Through discharge or 7 days post procedure

  2. Number of participants who died or experienced a stroke

    Composite of all-cause mortality and all stroke A Clinical Events Committee (CEC), independent group of physician experts will be used to evaluate all reported cases of death and stroke to determine whether they met the specific protocol definition of the event.

    Time frame: Through 30 Days post procedure

Other outcomes

  1. Number of participants who died including all-cause, cardiovascular, and non-cardiovascular death

    Adjudicated by an independent Clinical Events Committee (CEC) based on VARC 2 definitions

    Time frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1 year

  2. Number of participants who experienced a Stroke including disabling and non-disabling

    Adjudicated by an independent Clinical Events Committee (CEC) based on VARC 2 definitions

    Time frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1 year

  3. Number of participants with Myocardial infarction (MI): periprocedural (≤72 hours post index procedure) and spontaneous (>72 hours post index procedure)

    Adjudicated by an independent Clinical Events Committee (CEC) based on VARC 2 definitions

    Time frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1 year

  4. Number of participants with Bleeding: life-threatening (or disabling) and major

    Adjudicated by an independent Clinical Events Committee (CEC) based on VARC 2 definitions

    Time frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1 year

  5. Number of participants with Acute kidney injury based on the AKIN System Stage 3 (including renal replacement therapy) or Stage 2

    Adjudicated by an independent Clinical Events Committee (CEC) based on VARC 2 definitions

    Time frame: ≤7 days post index procedure

  6. Number of participants with Major vascular complication

    Adjudicated by an independent Clinical Events Committee (CEC) based on VARC 2 definitions

    Time frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1 year

  7. Number of participants with Repeat procedure for valve-related dysfunction (surgical or interventional therapy)

    Adjudicated by an independent Clinical Events Committee (CEC) based on VARC 2 definitions

    Time frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1 year

  8. Number of participants with Hospitalization for valve-related symptoms or worsening congestive heart failure (New York Heart Association [NYHA] class III or IV)

    Adjudicated by an independent Clinical Events Committee (CEC) based on VARC 2 definitions

    Time frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1 year

  9. Number of participants with New permanent pacemaker implantation (PPI) resulting from new or worsened conduction disturbances

    Adjudicated by an independent Clinical Events Committee (CEC) based on VARC 2 definitions

    Time frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1 year

  10. Number of participants with New onset of atrial fibrillation or atrial flutter

    Adjudicated by an independent Clinical Events Committee (CEC) based on VARC 2 definitions

    Time frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1 year

  11. Number of participants with Coronary obstruction: periprocedural

    Adjudicated by an independent Clinical Events Committee (CEC) based on VARC 2 definitions

    Time frame: ≤72 hours post index procedure

  12. Number of participants with Ventricular septal perforation: periprocedural

    Adjudicated by an independent Clinical Events Committee (CEC) based on VARC 2 definitions

    Time frame: ≤72 hours post index procedure

  13. Number of participants with Mitral apparatus damage: periprocedural

    Adjudicated by an independent Clinical Events Committee (CEC) based on VARC 2 definitions

    Time frame: ≤72 hours post index procedure

  14. Number of participants with Cardiac tamponade: periprocedural

    Adjudicated by an independent Clinical Events Committee (CEC) based on VARC 2 definitions

    Time frame: ≤72 hours post index procedure

  15. Number of participants with Valve migration

    Adjudicated by an independent Clinical Events Committee (CEC) based on VARC 2 definitions

    Time frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1 year

  16. Number of participants with Valve embolization

    Adjudicated by an independent Clinical Events Committee (CEC) based on VARC 2 definitions

    Time frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1 year

  17. Number of participants with Ectopic valve deployment

    Adjudicated by an independent Clinical Events Committee (CEC) based on VARC 2 definitions

    Time frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1 year

  18. Number of participants with Transcatheter aortic valve (TAV)-in-TAV deployment

    Adjudicated by an independent Clinical Events Committee (CEC) based on VARC 2 definitions

    Time frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1 year

  19. Number of participants with Prosthetic aortic valve thrombosis

    Adjudicated by an independent Clinical Events Committee (CEC) based on VARC 2 definitions

    Time frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1 year

  20. Number of participants with Prosthetic aortic valve endocarditis

    Adjudicated by an independent Clinical Events Committee (CEC) based on VARC 2 definitions

    Time frame: Participants will be followed for the duration of hospital stay, through 30 days, 6 months, and 1 year

  21. Number of participants with successful vascular access, delivery and deployment of the study valve, and successful retrieval of the delivery system (site reported assessment)

    Device Performance endpoint, as measured by site reported data

    Time frame: Participants will be followed for the duration of their procedure, an expected average of 1 day (peri- and post-procedure)

  22. Grade of aortic regurgitation/paravalvular leak (PVL) (echocardiographic assessment)

    Device Performance endpoint, as assessed by Echocardiographic Core Laboratory

    Time frame: Participants will be followed for the duration of their procedure, an expected average of 1 day (peri- and post-procedure)

  23. Prosthetic aortic valve performance: Effective Orifice Area (EOA)

    Effective Orifice Area (EOA), as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory

    Time frame: Discharge or 7 days post index procedure (whichever comes first), 30 days, 6 months, and 1 year

  24. Prosthetic aortic valve performance: Mean Aortic Gradient

    Mean aortic gradient as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory

    Time frame: Discharge or 7 days post index procedure (whichever comes first), 30 days, 6 months, and 1 year

  25. Prosthetic aortic valve performance: Peak Aortic Gradient

    Peak Aortic Gradient as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory

    Time frame: Discharge or 7 days post index procedure (whichever comes first), 30 days, 6 months, and 1 year

  26. Prosthetic aortic valve performance: Peak Aortic Velocity

    Peak Aortic Velocity as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory

    Time frame: Discharge or 7 days post index procedure (whichever comes first), 30 days, 6 months, and 1 year

  27. Prosthetic aortic valve performance: Grade of Aortic Regurgitation/PVL

    Grade of Aortic Regurgitation/PVL as measured by transthoracic echocardiography (TTE) and assessed by an independent core laboratory

    Time frame: Discharge or 7 days post index procedure (whichever comes first), 30 days, 6 months, and 1 year

  28. Number of participants with a New York Heart Association (NYHA) Functional Status classification of Class I, II, III or IV

    Evaluated by New York Heart Association (NYHA) classification

    Time frame: Discharge or 7 days post index procedure (whichever comes first), 30 days, 6 months, and 1 year

  29. Neurological status: Participant score for National Institutes of Health Stroke Scale (NIHSS) assessment

    Evaluated by National Institutes of Health Stroke Scale (NIHSS) - Minimum: 0 (No stroke symptoms); Max: 21-42 (Severe stroke)

    Time frame: Discharge or 7 days post index procedure (whichever comes first) and 1 year and when is stroke is suspected

  30. Neurological status: Participant score for Modified Rankin Scale (mRS) Assessment

    Evaluated by Modified Rankin Scale (mRS) - min: 0 (The patient has no residual symptoms); max: 6 (The patient has expired)

    Time frame: Discharge or 7 days post index procedure (whichever comes first), 30 days, 6 months, and 1 year, and when is stroke is suspected (and 90 days post stroke)

  31. Neurological status: Number of participants with a confirmed stroke per Neurological physical exam assessment

    Evaluated per neurological physical exam in all subjects where stroke is suspected

    Time frame: Participants will be followed for the duration of the trial, through 1 year

07

Study locations

3 sites
  • Royal Prince Alfred Hospital
    Camperdown, New South Wales 2050, Australia
  • The Prince Charles Hospital
    Brisbane, Queensland 4032, Australia
  • Monash Health
    Clayton, Victoria 3168, Australia
08

References and documents

Individual participant data

Plan to share: Undecided — The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html)

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05224245
Lead sponsor
Boston Scientific Corporation
Responsible party
Sponsor
First posted
Feb 4, 2022
Start date
Mar 3, 2022
Primary completion
Jun 16, 2022
Completion
May 24, 2023
Last update
Jun 15, 2023

Study contacts

Robert Gooley, MBBS
principal investigator · Monash Medical Centre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Aortic Valve Stenosis→

Other studies from this sponsor

Boston Scientific Corporation

Start the discussion