ACURATE Enhance Post Market Study (NCT06959862) | Clinical Trial Compass
WithdrawnNot Applicable
ACURATE Enhance Post Market Study
Stopped: Boston Scientific made the decision to discontinue worldwide commercialization of the ACURATE valve platform.
0Started 2025-05
Plain-language summary
The objective of the ACURATE Enhance study is to assess valve frame expansion and hemodynamics in a routine clinical setting when optimized procedural steps for valve implantation are followed.
Who can participate
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject has documented severe aortic stenosis and an aortic annulus size compatible with the ACURATE neo2 valve per the commercial IFU based on the center's assessment of pre-procedure diagnostic imaging, and is deemed suitable for treatment with the ACURATE neo2™ Aortic Valve System (or future commercially available iteration) as confirmed by the Case Review Committee \[CRC\].
* Subject (or legal representative) understands the study requirements and provides written informed consent (eg, IEC-approved ICF).
* Subject, family member, and/or legal representative agree(s) and subject is capable of returning to the study hospital for all study required follow-up visits.
Exclusion Criteria:
* Subject has a previously implanted bioprosthesis in the aortic position.
* Subject has a unicuspid or bicuspid aortic valve.
* 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.
* Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated or to the individual components of the study valve (nickel, titanium, processed porcine pericardium, polyet…