NCT04655248

ACURATE neo2™ Post Market Clinical Follow up Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The ACURATE Neo2 PMCF is aimed at collecting clinical and device performance outcomes data with the ACURATE neo2™ Transfemoral Aortic Valve System as used in routine clinical practice for the treatment of severe calcific aortic stenosis.

Detailed description

ACURATE neo2 PMCF is a prospective, open-label, single-arm, multicenter, observational post-market surveillance study. All subjects deemed treatable with the ACURATE neo2 valve will be approached to participate in the study. 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 commercially available ACURATE neo2 Transfemoral Delivery System. Approximately 200 subjects will be enrolled. Follow-up will occur at pre-discharge, 30 days, 1 year, and then annually from 2 through 5 years post index procedure per standard of care. Visits are in-person through 1 year and in-person (preferred) or via telephone interview in years 2 through 5. All subjects will undergo 4D computed tomography (CT) imaging at 30 days and 1 year. ACURATE neo2 PMCF Study Design Overview Abbreviations: CT=computed tomography; ICF=Informed Consent Form

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: 2020-12-16
• Primary completion: 2022-03-09
• Completion: 2026-12-31
• First posted: 2020-12-07
• Last updated: 2025-06-25

Locations

19 sites across 8 countries: Denmark, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom