Active, currently enrolling
ACURATE IDE: Transcatheter Replacement of Stenotic Aortic Valve Through Implantation of ACURATE in Subjects InDicatEd for TAVR
NCT No.: NCT03735667
Study Type: INTERVENTIONAL
Phase:
n/a
Region: California - Northern
Acronym:
Official Title
ACURATE IDE: Transcatheter Replacement of Stenotic Aortic Valve Through Implantation of ACURATE in Subjects InDicatEd for TAVR
Purpose
To evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.
Detailed Description
Subjects will be enrolled at up to 50 centers in the United States and Canada.
There will be up to 600 subjects in ACURATE IDE.
The ACURATE IDE study cohorts include the following:
Randomized Cohort: A prospective, multicenter, 1:1 randomized controlled trial (RCT, ACURATE versus a commercially available balloon-expandable SAPIEN 3™ Transcatheter Heart Valve or future iteration [SAPIEN 3, Edwards Lifesciences LLC, Irvine, CA, USA] or a commercially available self-expanding CoreValve® Transcatheter Aortic Valve Replacement System, CoreValve® Evolut™ R Recapturable TAVR System, EVOLUT™ PRO System, or future iteration [CoreValve, Medtronic, Inc., Dublin, Ireland]). There will be up to 500 subjects in the RCT.
Roll-In Cohort: A non-randomized roll-in phase with the test device. Centers that do not have implantation experience with the ACURATE neo™ Aortic Bioprosthesis (transfemoral delivery, Symetis SA, Ecublens, Switzerland) will perform at least 2 roll-in cases before commencing enrollment in the randomized cohort. Centers with prior experience with ACURATE are not required to do roll-in cases. Data from roll-in subjects will be summarized separately from the randomized cohort and will not be included in the primary endpoint analysis.
All subjects implanted will be followed at baseline, peri- and post-procedure, at discharge or 7 days post-procedure (whichever comes first), 30 days, 6 months, and then annually for up to 5 years post-procedure. Enrolled subjects who do not have a study device implanted will be assessed through 1-year post-procedure for safety/adverse events.
Age Limit
0 years & older
Eligibility Criteria
Inclusion Criteria
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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;
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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)76, the subject may be enrolled if echocardiographic criteria are met with this augmentation;
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IC2. Subject has a documented aortic annulus size of >=21 mm and <=27 mm based on the center's assessment of pre-procedure diagnostic imaging (and confirmed by the Case Review Committee [CRC]) and, for the randomized cohort, is deemed treatable with an available size of both test and control device;
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IC3. For subjects with symptomatic aortic valve stenosis per IC1 definition above, functional status is NYHA Functional Class >= II;
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IC4. Heart team (which must include an experienced cardiac interventionalist and an experienced cardiac surgeon) agrees that the subject has an on-label United States Food and Drug Administration (FDA) approved indication for TAVR and TAVR is appropriate. Heart team should consider the STS score as well as other factors including frailty, prior surgical history, malignancy or radiation therapy, deformity, and aortic calcification;
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Please contact study team for more eligibility criteria.
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Exclusion Criteria
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Subject has a unicuspid or bicuspid aortic valve;
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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);
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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;
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Subject is on renal replacement therapy or has eGFR <=20;
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Subject has a pre-existing prosthetic aortic or mitral valve;
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Subject has severe (4+) aortic, tricuspid, or mitral regurgitation;
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Subject has moderate or severe mitral stenosis (mitral valve area <=1.5 cm2 and diastolic pressure half-time >=150 ms, Stage C or D76);
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Subject has a need for emergency surgery for any reason;
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Subject has a history of endocarditis within 6 months of index procedure or evidence of an active systemic infection or sepsis;
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Subject has echocardiographic evidence of new intra-cardiac vegetation or intraventricular or paravalvular thrombus requiring intervention;
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Please contact study team for more eligibility criteria;
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Keywords and/or Specific Medical Conditions
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S2408
Aortic Valve Stenosis
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Ventricular Outflow Obstruction
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Sponsors
- Boston Scientific/EP Technologies
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