ACURATE Enhance Post Market Study

NCT06959862 | Withdrawn

• 1 other identifier: S2532
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Aortic Valve Stenosis; Aortic Valve Calcification; Aortic Diseases

Outcome Measures

Primary Outcomes (1)

• 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.

  Index procedure

Secondary Outcomes (1)

• Secondary Endpoint

  30 days

Other Outcomes (6)

• Safety endpoints adjudicated by an independent Clinical Events Committee

  Peri- and post-procedure, pre-discharge or 7 days (whichever comes first), and 30 days, 6 months, and 1 year

• Additional safety endpoints adjudicated by an independent Clinical Events Committee

  Peri- and post-procedure, pre-discharge or 7 days (whichever comes first), and 30 days, 6 months, and 1 year

• Safety endpoints per VARC-3

  Post-procedure, 30 days and 1 year

Interventions

Transcatheter Aortic Valve Implantation/Replacement DEVICE

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 Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic heart disease due to severe native calcific aortic stenosis

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

MeSH Terms

Conditions

Aortic Valve Stenosis; Aortic Valve, Calcification of; Aortic Diseases

Interventions

Transcatheter Aortic Valve Replacement; Replantation

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Vascular Diseases

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures; Transplantation

Study Officials

• Andreas Rück

  Karolinska Universitetssjukhuset, Enheten för kardiologi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 7, 2025
• Study Start: May 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 24, 2025

Record last verified: 2025-06