Status:
WITHDRAWN
ACURATE Enhance Post Market Study
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Aortic Valve Stenosis
Aortic Valve Calcification
Eligibility:
All Genders
Brief 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.
Detailed Description
ACURATE Enhance is a prospective, open-label, single-arm, multicenter, post-market study in patients implanted with the ACURATE neo2™ Aortic Valve System (or future commercially available iteration) f...
Eligibility Criteria
Inclusion
- 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
- 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, polyethylene terephthalate \[PET\]).
- Subject has eGFR \<30 mL/min (chronic kidney disease stage IV or stage V).
- Subject is unwilling or unable to undergo study required follow-up visits.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2027
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06959862
Start Date
May 1 2025
End Date
April 1 2027
Last Update
June 24 2025
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