MedTrace Logo

ACURATE neo2™ Post Market Clinical Follow up Study

NCT04655248 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2025-06-25

No results posted yet for this study

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.

Conditions

  • Aortic Valve Stenosis
  • Aortic Valve Calcification
  • Aortic Diseases

Interventions

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

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Won-Keun Kim, MD · Kerckhoff Klinik

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-16
Primary Completion
2022-03-09
Completion
2026-12-31

Countries

  • Denmark
  • Germany
  • Italy
  • Netherlands
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04655248 on ClinicalTrials.gov