NCT06959862

ACURATE Enhance Post Market Study

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Valve Stenosis
• Aortic Valve Calcification
• Aortic Diseases

Interventions

Type	Name	Description
DEVICE	Transcatheter Aortic Valve Implantation/Replacement	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

Timeline

• Start date: 2025-05-01
• Primary completion: 2025-12-01
• Completion: 2027-04-01
• First posted: 2025-05-07
• Last updated: 2025-06-24