Clinical trial NCT06959862: ACURATE Enhance Post Market Study
Official title: ACURATE Enhance Post Market Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Aortic Valve Stenosis
Aortic Valve Calcification
Aortic Diseases
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2025-05-07
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic heart disease due to severe native calcific aortic stenosis

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) 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary Endpoint:
timeFrame: Index procedure
Secondary outcomes:
measure: Secondary Endpoint
timeFrame: 30 days
Other outcomes:
measure: Safety endpoints adjudicated by an independent Clinical Events Committee
timeFrame: Peri- and post-procedure, pre-discharge or 7 days (whichever comes first), and 30 days, 6 months, and 1 year
measure: Additional safety endpoints adjudicated by an independent Clinical Events Committee
timeFrame: Peri- and post-procedure, pre-discharge or 7 days (whichever comes first), and 30 days, 6 months, and 1 year
measure: Safety endpoints per VARC-3
timeFrame: Post-procedure, 30 days and 1 year
measure: New York Heart Association (NYHA) functional classification
timeFrame: baseline, pre-discharge/7 days, 30 days, and 1 year
measure: Prosthetic Aortic Valve Performance as measured by transthoracic echocardiography (TTE)
timeFrame: Pre-discharge/7days, 30 days, and 1 year
measure: Patient reported outcomes and health status
timeFrame: baseline, 30 days and 1-year
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Giessen
country: Germany
facility: Universitatsklinikum Giessen und Marburg
city: Lund
country: Sweden
facility: Lund University, Cardiology department
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset, Enheten för kardiologi
Study officials:
affiliation: Karolinska Universitetssjukhuset, Enheten för kardiologi
name: Andreas Rück
role: PRINCIPAL_INVESTIGATOR
References: