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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Stenosis
- Sponsor
- Boston Scientific Corporation
- Enrollment
- 13
- Locations
- 3
- Primary Endpoint
- Number of participants with Device Success
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
- •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 \[CRC\]).
- •For subjects with symptomatic aortic valve stenosis per IC1 definition above, functional status is NYHA Functional Class ≥ II.
- •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.
- •Subject (or legal representative) understands the study requirements and the treatment procedures and provides written informed consent.
- •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.
- •Subject is expected to be able to take the protocol-required adjunctive pharmacologic therapy.
Exclusion Criteria
- •Subject has a unicuspid or bicuspid aortic valve.
- •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.
- •Subject has a pre-existing prosthetic aortic or mitral valve.
- •Subject has severe (4+) aortic, tricuspid, or mitral regurgitation.
- •Subject has moderate or severe mitral stenosis (mitral valve area ≤1.5 cm2 and diastolic pressure half-time ≥150 ms, Stage C or D).
- •Subject has a need for emergency surgery for any reason.
- •Subject has a history of endocarditis within 6 months of index procedure or evidence of an active systemic infection or sepsis.
- •Subject has echocardiographic evidence of new intra-cardiac vegetation or intraventricular or paravalvular thrombus requiring intervention.
Outcomes
Primary Outcomes
Number of participants with Device Success
Time Frame: Through discharge or 7 days post procedure
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.
Number of participants who died or experienced a stroke
Time Frame: Through 30 Days post procedure
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.