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CoreValve Advance International Post Market Study

NCT ID: NCT01074658

Last Updated: 2017-12-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1015 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2017-05-31

Brief Summary

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The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic CoreValve System in a "Real-World" patient population.

Detailed Description

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The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic CoreValve System for percutaneous aortic valve implantation in a "Real-World" patient population with severe aortic valve stenosis. Data collected in this study will provide additional information on the understanding of the safety and device performance and how to best treat elderly patients with severe aortic valve stenosis. In addition, health economic data will be collected to understand the improvement of quality of life and the cost effectiveness of the therapy.

Conditions

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Severe Aortic Stenosis

Keywords

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Advance Medtronic CoreValve System International Interventional Post Market Study

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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severe aortic valve stenosis

elderly patients with severe aortic valve stenosis requiring treatment

Medtronic CoreValve System

Intervention Type DEVICE

Transcatheter Aortic Valve Implantation of the Medtronic CoreValve System

Interventions

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Medtronic CoreValve System

Transcatheter Aortic Valve Implantation of the Medtronic CoreValve System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with severe aortic valve stenosis requiring treatment
* Patient is an acceptable candidate for elective treatment with the Medtronic CoreValve System and in conformity with the local regulatory and medico economical context
* Patient is above the minimum age as required by local regulations to be participating in a clinical study
* The patient or legal representative has been informed of the nature of the study and has consented to participate, and has authorized the collection and release of his/her medical information by signing a consent form ("Patient Informed Consent Form")

Exclusion Criteria

* Currently participating in another trial
* High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
* Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Axel Linke, Prof Dr med

Role: PRINCIPAL_INVESTIGATOR

Universitat Leipzig Herzzentrum

Locations

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ZNA Antwerpen Middelheim

Antwerp, , Belgium

Site Status

Antwerpen UZA

Antwerp, , Belgium

Site Status

CHU Sart Tillman

Liège, , Belgium

Site Status

Angiografia de Occidente

Cali, , Colombia

Site Status

Rigshospitalet

Copenhagen, , Denmark

Site Status

Hopital Henri Mondor

Créteil, , France

Site Status

Hopital Cardiologique

Lille, , France

Site Status

Hopital Louis Pradel

Lyon, , France

Site Status

Institut Hospitalier Jacques Cartier

Massy, , France

Site Status

Groupe Hospitalier Pitie-Salpetriere

Paris, , France

Site Status

Clinique Pasteur

Toulouse, , France

Site Status

Universitätsklinikum Aachen

Aachen, , Germany

Site Status

Bernau Herzzentrum Brandenburg

Bernau B. Berlin, , Germany

Site Status

CardioVascular Center Frankfurt

Frankfurt, , Germany

Site Status

Asklepios Klinik St. Georg Hamburg

Hamburg, , Germany

Site Status

Universitat Leipzig Herzzentrum

Leipzig, , Germany

Site Status

Deutsches Herzzentrum Munchen

München, , Germany

Site Status

Helios Herzzentrum Siegburg Gmbh

Siegburg, , Germany

Site Status

Onassis cardiac surgery center

Athens, , Greece

Site Status

Hadassah Medical Center

Jerusalem, , Israel

Site Status

Sheba Medical Center

Tel Aviv, , Israel

Site Status

Ichilov Medical Center

Tel Aviv, , Israel

Site Status

Azienda Ospedaliere Spedali Civili di Brescia

Brescia, , Italy

Site Status

Policlinico Vittorio Emanuele, P.O. Ferrarotto

Catania, , Italy

Site Status

Azienda Ospedaliero-Universitaria Careggi

Florence, , Italy

Site Status

Ospedale Civile

Legnano, , Italy

Site Status

Ospedale Niguarda Ca'Granda

Milan, , Italy

Site Status

Fondazione Centro San Raffaele

Milan, , Italy

Site Status

Istituto Clinico S.Ambrogio

Milan, , Italy

Site Status

Istituto Clinico Humanitas

Rozzano, , Italy

Site Status

AMC Ziekenhuis

Amsterdam, , Netherlands

Site Status

Amphia Breda

Breda, , Netherlands

Site Status

Catharina Hospital

Eindhoven, , Netherlands

Site Status

St. Antonius Ziekenhuis

Nieuwegein, , Netherlands

Site Status

Hospital de Santa Cruz

Lisbon, , Portugal

Site Status

Centro Hospitalar de Vila Nova de Gaia

Porto, , Portugal

Site Status

Universtiy Hospital Isel Bern

Bern, , Switzerland

Site Status

Universitätsspital Zürich

Zurich, , Switzerland

Site Status

Brighton and Sussex Hospital

Brighton, , United Kingdom

Site Status

Leeds General Infirmary

Leeds, , United Kingdom

Site Status

Leicester Hospital

Leicester, , United Kingdom

Site Status

St. George's Hospital

London, , United Kingdom

Site Status

The Heart Hospital

London, , United Kingdom

Site Status

Newcross Hospital Wolverhampton

Wolverhampton, , United Kingdom

Site Status

Countries

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Austria Spain Sweden Belgium Colombia Denmark France Germany Greece Israel Italy Netherlands Portugal Switzerland United Kingdom

References

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Gerckens U, Tamburino C, Bleiziffer S, Bosmans J, Wenaweser P, Brecker S, Guo J, Linke A. Final 5-year clinical and echocardiographic results for treatment of severe aortic stenosis with a self-expanding bioprosthesis from the ADVANCE Study. Eur Heart J. 2017 Sep 21;38(36):2729-2738. doi: 10.1093/eurheartj/ehx295.

Reference Type DERIVED
PMID: 28633375 (View on PubMed)

Bleiziffer S, Bosmans J, Brecker S, Gerckens U, Wenaweser P, Tamburino C, Linke A; ADVANCE Study Investigators. Insights on mid-term TAVR performance: 3-year clinical and echocardiographic results from the CoreValve ADVANCE study. Clin Res Cardiol. 2017 Oct;106(10):784-795. doi: 10.1007/s00392-017-1120-3. Epub 2017 May 8.

Reference Type DERIVED
PMID: 28484830 (View on PubMed)

Brecker SJ, Bleiziffer S, Bosmans J, Gerckens U, Tamburino C, Wenaweser P, Linke A; ADVANCE Study Investigators. Impact of Anesthesia Type on Outcomes of Transcatheter Aortic Valve Implantation (from the Multicenter ADVANCE Study). Am J Cardiol. 2016 Apr 15;117(8):1332-8. doi: 10.1016/j.amjcard.2016.01.027. Epub 2016 Jan 28.

Reference Type DERIVED
PMID: 26892451 (View on PubMed)

Barbanti M, Schiltgen M, Verdoliva S, Bosmans J, Bleiziffer S, Gerckens U, Wenaweser P, Brecker S, Gulino S, Tamburino C, Linke A; ADVANCE Study Investigators. Three-Year Outcomes of Transcatheter Aortic Valve Implantation in Patients With Varying Levels of Surgical Risk (from the CoreValve ADVANCE Study). Am J Cardiol. 2016 Mar 1;117(5):820-7. doi: 10.1016/j.amjcard.2015.11.066. Epub 2015 Dec 13.

Reference Type DERIVED
PMID: 26762727 (View on PubMed)

Bosmans J, Bleiziffer S, Gerckens U, Wenaweser P, Brecker S, Tamburino C, Linke A; ADVANCE Study Investigators. The Incidence and Predictors of Early- and Mid-Term Clinically Relevant Neurological Events After Transcatheter Aortic Valve Replacement in Real-World Patients. J Am Coll Cardiol. 2015 Jul 21;66(3):209-217. doi: 10.1016/j.jacc.2015.05.025.

Reference Type DERIVED
PMID: 26184612 (View on PubMed)

Other Identifiers

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Advance

Identifier Type: -

Identifier Source: org_study_id