ACURATE Prime XL Human Feasibility Study

NCT05224245 | Completed

• 1 other identifier: S2458
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Aortic Stenosis

Keywords

ACURATE Prime™ XL Aortic Valve System

Outcome Measures

Primary Outcomes (2)

• 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.

  Through discharge or 7 days post procedure

• 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.

  Through 30 Days post procedure

Other Outcomes (31)

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

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

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

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

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

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

Study Arms (1)

Single arm: ACURATE Prime XL Transfemoral Aortic Valve System

EXPERIMENTAL

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

ACURATE Prime XL Transfemoral Aortic Valve System DEVICE

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).

Single arm: ACURATE Prime XL Transfemoral Aortic Valve System

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (3)

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

The Prince Charles Hospital

Brisbane, Queensland, 4032, Australia

Location

Monash Health

Clayton, Victoria, 3168, Australia

Location

Related Publications (1)

• Gooley R, Murdoch D, Ng MK, Modolo R, Allocco DJ. First results from the ACURATE Prime XL human feasibility study. Cardiovasc Revasc Med. 2023 Dec;57:1-5. doi: 10.1016/j.carrev.2023.06.028. Epub 2023 Jun 30.

  PMID: 37429793 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Robert Gooley, MBBS

  Monash Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The protocol allows for up to 20 patients to be enrolled.

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: February 4, 2022
• Study Start: March 3, 2022
• Primary Completion: June 16, 2022
• Study Completion: May 24, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

AU (3)