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PRospective Observation of Aortic reGuRgitation aftEr TAVI and progreSS Over Time: PROGRESS PVL Registry

NCT ID: NCT02987894

Last Updated: 2020-04-09

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

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-02

Study Completion Date

2019-09-30

Brief Summary

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The purpose of this post-market registry is to collect and monitor ongoing safety and performance clinical data of the ACURATE neo™ Aortic Bioprosthesis, and the ACURATE TF™ Transferral Delivery System, when used as per IFU.

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Detailed Description

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The primary objective of this post-market registry is to further evaluate the safety and performance of the ACURATE neo™ Aortic Bioprosthesis and the ACURATE TF™ Transferral Delivery System in 500 consented patients with severe aortic stenosis and treated according to the instructions for use (IFU).

Examinations to evaluate the aortic valve regurgitation performed as standard of care in patients undergoing transcatheter aortic valve replacement will be analyzed by an external Core Laboratory. These examinations are limited to echocardiography and/or contrast aortography assessments.

The secondary objective is to collect adverse events and evaluate them according to the VARC-2 consensus document.

Conditions

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Aortic Stenosis

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. Transfemoral access.

Intervention Type DEVICE

Other Intervention Names

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ACURATE TF™ Transfemoral Delivery System

Eligibility Criteria

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Inclusion Criteria

1. Patient is included in the registry if eligible for transcatheter treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions for Use (Patients which are included but treated outside of the approved indication will be followed for safety reasons).
2. Patient is willing to participate in the study, provides signed Informed Consent/Data Authorization Form and authorizes the sharing of data in the registry. Patient agrees that anonymized imaging data will be sent to and analyzed by an external Core Laboratory.
3. The treating physician should ensure the subject will return for all required post procedure follow-up visits.

Exclusion Criteria

1\. Patients are excluded from the registry if they are not eligible for transcatheter treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions For Use.
Minimum Eligible Age

75 Years

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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Won-Keun Kim, Dr

Role: PRINCIPAL_INVESTIGATOR

Kerckhoff-Klinik Forschungsgesellschaft mbH

Locations

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London Health Sciences Centre, University Hospital

London, Ontario, Canada

Site Status

Saint Paul's Hospital, Porvidence Health Care Institute

Vancouver, , Canada

Site Status

Klinikum Augsburg

Augsburg, , Germany

Site Status

Zentralklinik Bad Berka

Bad Berka, , Germany

Site Status

Kerkhoff Kilnik

Bad Nauheim, , Germany

Site Status

Immanuel Hospital Bernau- Herzzentrum Brandenburg

Bernau, , Germany

Site Status

Universitätsklinikum

Cologne, , Germany

Site Status

Sana-Herzzentrum Cottbus GmbH

Cottbus, , Germany

Site Status

St Johannes Hospital

Dortmund, , Germany

Site Status

Goethe Universität

Frankfurt, , Germany

Site Status

Universitätklinikum Giessen

Giessen, , Germany

Site Status

Universitätsklinikum Halle

Halle, , Germany

Site Status

Universitätsklinikum Jena

Jena, , Germany

Site Status

Städisches Klinikum Karlsruhe GmbH

Karlsruhe, , Germany

Site Status

Helios Klinik Fur Herzzchirurgie Karlsruhe

Karlsruhe, , Germany

Site Status

Sana Herzzentrum Leipzig

Leipzig, , Germany

Site Status

Universitätsklinikum Münster

Münster, , Germany

Site Status

Städische Kliniken

Neuss, , Germany

Site Status

Universitätsklinikum Tübingen

Tübingen, , Germany

Site Status

Ospedale Civile di Legnano

Legnano, , Italy

Site Status

Fondazione Toscana G.Monasterio, Ospedale del Cuore G.Pasquinucci

Massa, , Italy

Site Status

University Hospital NHS

Leicester, , United Kingdom

Site Status

Oford University Hospital

Oxford, , United Kingdom

Site Status

Countries

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Canada Germany Italy United Kingdom

Other Identifiers

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2016-02

Identifier Type: -

Identifier Source: org_study_id

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