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ACURATE Neo™ AS Aortic Bioprosthesis for Implantation Using the ACURATE neoTM AS TF Transfemoral Delivery System in Patients With Severe Aortic Stenosis

NCT02909556 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-02-16

No results posted yet for this study

Summary

Clinical trial aimed at evaluating the safety and performance of the ACURATE neo™ AS Aortic Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System for CE mark approval purposes.

Conditions

  • Aortic Stenosis

Interventions

DEVICE

Transcatheter aortic valve replacement

Transcatheter aortic valve replacement via transfemoral access

Sponsors & Collaborators

  • Symetis SA

    lead INDUSTRY

Principal Investigators

  • Helge Möllmann, Prof. · Klinik für Innere Medizin - St.-Johannes-Hospital - Dortmund, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-16
Primary Completion
2018-01-24
Completion
2023-01-13

Countries

  • Denmark
  • Germany
  • Switzerland

Study Locations

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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 NCT02909556 on ClinicalTrials.gov