ACURATE Enhance Post Market Study

Boston Scientific Corporation

Overview

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.

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.

Study Type

OBSERVATIONAL

Conditions

Aortic Valve Stenosis Aortic Valve Calcification Aortic Diseases

Interventions

Transcatheter Aortic Valve Implantation/ReplacementDEVICE

The device is placed in patients heart at the level of aortic valve through a transfemoral access from femoral groin as indicated in device IFU

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Primary Endpoint:

Proportion of patients who achieve target valve frame expansion\* at the end of the index procedure when following optimized procedural steps. \* "Target valve frame expansion" is defined as visual evidence of parallel commissure posts, as confirmed by an independent core laboratory evaluation of procedural angiogram.

Time frame: Index procedure

Secondary Outcomes

Secondary Endpoint

All-cause mortality (cardiovascular and non-cardiovascular), Stroke (disabling and non-disabling) and Rehospitalization\* at 30 days. \* Rehospitalization refers to procedure-related or valve-related hospitalization, and includes the following as defined by VARC-3: hospitalization for new complications, bioprosthetic valve dysfunction (such as valve thrombosis, endocarditis, structural valve deterioration, or non-structural valve dysfunction), or heart-failure related hospitalizations.

Time frame: 30 days

Data from ClinicalTrials.gov

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