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

NCT ID: NCT03454360

Last Updated: 2020-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

107 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-06

Study Completion Date

2020-04-30

Brief Summary

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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.

Detailed Description

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The Primary Objective of this post-market registry is to collect specific health and patient characteristics to understand the indication for TA-TAVI and to further evaluate the safety and performance of the ACURATE neo ™ Aortic Bioprosthesis and ACURATE neo™ TA Transapical Delivery System in a specific TA population, consisting of 200 consented patients.

Conditions

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Aortic Stenosis

Keywords

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TAVI Transcatheter Aortic Valve Replacement Transcatheter Aortic Valve Transapical Access

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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ACURATE neo™ Aortic Bioprosthesis

TAVI; Transcatheter Aortic Valve Replacement. Transapical Access.

Intervention Type DEVICE

Other Intervention Names

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ACURATE neo™ TA Delivery System

Eligibility Criteria

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Inclusion Criteria

* Symptomatic patients with severe aortic stenosis;
* Institution heart team determines that aortic valve replacement ACURATE neoTM device using its transapical delivery system is appropriate;

Exclusion Criteria

\- Patients unable or unwilling to give inform consent;
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Symetis SA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Hilker, Prof.Dr.med

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Regensburg

Locations

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Kerckhoff Klinik

Bad Nauheim, , Germany

Site Status

Herz-und Gefäß-Kilink GmbH

Bad Neustadt an der Saale, , Germany

Site Status

Krankenhausbetriebgesellschaft

Bad Oeynhausen, , Germany

Site Status

BG Klinik Bergmannsheil

Bochum, , Germany

Site Status

Universitätsklinikum Frankfurt- Klinik für Thorax, Herz und thorakale Gefæßchirurgie

Frankfurt, , Germany

Site Status

Universitäts-Herzzentrum Freiburg-Bad Krozingen

Freiburg im Breisgau, , Germany

Site Status

Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Herzzentrum Leipzig

Leipzig, , Germany

Site Status

Deutsches Herzzentrum München

München, , Germany

Site Status

Universitätsklinikum Regensburg

Regensburg, , Germany

Site Status

Countries

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Italy Switzerland Germany

Other Identifiers

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2016-03

Identifier Type: -

Identifier Source: org_study_id