ACURATE Enhance Post Market Study

Boston Scientific

Status: Not yet enrolling

Conditions: Aortic Valve Stenosis; Aortic Diseases; Aortic Valve Calcification

Treatments: Device: Transcatheter Aortic Valve Implantation/Replacement

Study type: Observational

Funder types: Industry

Identifiers

NCT06959862

S2532

Details and patient eligibility

About

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.

Full 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) for the treatment of severe calcific aortic stenosis in a routine clinical setting.

A subject who provides an Informed Consent Form (ICF) approved by the Independent Ethics Committee (IEC) and signed by the subject or the subject's legally authorized representative is considered enrolled once an attempt is made to insert the ACURATE neo2 Delivery System. Up to 150 subjects will be enrolled.

Follow-up will occur at pre-discharge, 30 days, 6 months and 1 year post index procedure per standard of care. Visits are in-person at 30 days and 1 year. The 6 month visits is in-person (preferred) or via telephone interview.

Enrollment: 150 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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, 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.