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CHANGE Neo™ TA Registry With ACURATE Neo™ Aortic Bioprosthesis and ACURATE Neo™ TA Transapical Delivery System

NCT03454360 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 107

Last updated 2020-12-11

No results posted yet for this study

Summary

The purpose of this registry is to collect specific health and patient data to identify more precisely the patient population undergoing TA aortic valve replacement with the ACURATE neo™ Aortic biprosthesis and ACURATE neo™ TA Transapical Delivery System.

Safety and efficacy data will be collected to support the commercial use of the ACURATE neo™ Aortic Bioprosthesis and ACURATE neo™ TA Transapical Delivery System in a specific TA population.

As per IFU, the ACURATE neo™ and its ACURATE neo™ TA Delivery System are intended for use in minimally invasive, transcatheter aortic valve replacement using transapical access in patients presenting with severe aortic valve stenosis.

Conditions

  • Aortic Stenosis

Interventions

DEVICE

ACURATE neo™ Aortic Bioprosthesis

TAVI; Transcatheter Aortic Valve Replacement. Transapical Access.

Sponsors & Collaborators

  • Symetis SA

    lead INDUSTRY

Principal Investigators

  • Michael Hilker, Prof.Dr.med · Universitätsklinikum Regensburg

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-06
Primary Completion
2020-04-30
Completion
2020-04-30

Countries

  • Germany

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 NCT03454360 on ClinicalTrials.gov