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| Overall Recruitment Status: Active, currently enrolling |
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| Official Title |
| ACURATE IDE: Transcatheter Replacement of Stenotic Aortic Valve Through Implantation of ACURATE in Subjects InDicatEd for TAVR |
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| Region |
Sponsors |
| California - Northern |
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| Acronym |
KP IRB No. |
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1420623 |
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| Study Type |
Phase |
| Clinical Trial |
n/a |
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| Study Population Description |
| Individuals with documented severe symptomatic native aortic stenosis. |
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| 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. |
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| 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. |
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| Gender |
Age Limit |
| Male & Female |
0 years & older |
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- IC1. Subject has documented severe symptomatic native aortic stenosis defined as follows: aortic valve area (AVA) /=40 mmHg, OR maximal aortic valve velocity =4.0 m/s, OR Doppler velocity index
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Note: In cases of low flow, low gradient aortic stenosis with left ventricular dysfunction (ejection fraction
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IC2. Subject has a documented aortic annulus size of >/=21 mm and
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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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- 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
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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 /=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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Ventricular Outflow Obstruction
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