CoreValve Advance International Post Market Study

NCT01074658 | Completed Results

• 1 other identifier: Advance
• Study Type: observational
• Target: 1,015
• Locations: 12 countries
• Sites: 44

Brief Summary

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

Conditions

Severe Aortic Stenosis

Keywords

Advance; Medtronic CoreValve System; International; Interventional; Post Market Study

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiac & Cerebrovascular Events (MACCE)

  MACCE is defined as a composite of: * All cause mortality * Myocardial Infarction (Q-wave and non-Q-wave) * Emergent cardiac surgery or percutaneous re-intervention * Stroke The Kaplan-Meier survival analysis was used to derive the freedom from MACCE at 30 days.

  30 days

Secondary Outcomes (2)

• Percentage of Participants With Device Success

  up to 24 hours

• Percentage of Participants With Procedural Success

  up to 30 days

Study Arms (1)

severe aortic valve stenosis

elderly patients with severe aortic valve stenosis requiring treatment

Device: Medtronic CoreValve System

Interventions

Medtronic CoreValve System DEVICE

Transcatheter Aortic Valve Implantation of the Medtronic CoreValve System

severe aortic valve stenosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with severe aortic valve stenosis requiring treatment, who are selected to be treated electively with the Medtronic CoreValve System

You may qualify if:

• 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")

You may not qualify if:

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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (44)

ZNA Antwerpen Middelheim

Antwerp, 2020, Belgium

Location

Antwerpen UZA

Antwerp, 2650, Belgium

Location

CHU Sart Tillman

Liège, 4000, Belgium

Location

Angiografia de Occidente

Cali, Colombia

Location

Rigshospitalet

Copenhagen, DK2100, Denmark

Location

Hopital Henri Mondor

Créteil, 94010, France

Location

Hopital Cardiologique

Lille, 59037, France

Location

Hopital Louis Pradel

Lyon, 69677, France

Location

Institut Hospitalier Jacques Cartier

Massy, 91300, France

Location

Groupe Hospitalier Pitie-Salpetriere

Paris, 75013, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

Universitätsklinikum Aachen

Aachen, 52057, Germany

Location

Bernau Herzzentrum Brandenburg

Bernau B. Berlin, 16321, Germany

Location

CardioVascular Center Frankfurt

Frankfurt, 60389, Germany

Location

Asklepios Klinik St. Georg Hamburg

Hamburg, 20099, Germany

Location

Universitat Leipzig Herzzentrum

Leipzig, 04289, Germany

Location

Deutsches Herzzentrum Munchen

München, 80636, Germany

Location

Helios Herzzentrum Siegburg Gmbh

Siegburg, 53721, Germany

Location

Onassis cardiac surgery center

Athens, 17674, Greece

Location

Hadassah Medical Center

Jerusalem, 91120, Israel

Location

Sheba Medical Center

Tel Aviv, 52621, Israel

Location

Ichilov Medical Center

Tel Aviv, 64239, Israel

Location

Azienda Ospedaliere Spedali Civili di Brescia

Brescia, 25123, Italy

Location

Policlinico Vittorio Emanuele, P.O. Ferrarotto

Catania, 95024, Italy

Location

Azienda Ospedaliero-Universitaria Careggi

Florence, 50134, Italy

Location

Ospedale Civile

Legnano, Italy

Location

Ospedale Niguarda Ca'Granda

Milan, 20025, Italy

Location

Fondazione Centro San Raffaele

Milan, Italy

Location

Istituto Clinico S.Ambrogio

Milan, Italy

Location

Istituto Clinico Humanitas

Rozzano, 20089, Italy

Location

AMC Ziekenhuis

Amsterdam, 1100 DD, Netherlands

Location

Amphia Breda

Breda, 4818 CK, Netherlands

Location

Catharina Hospital

Eindhoven, 5623 EJ, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, 3435 CM, Netherlands

Location

Hospital de Santa Cruz

Lisbon, 2799-523, Portugal

Location

Centro Hospitalar de Vila Nova de Gaia

Porto, 4400, Portugal

Location

Universtiy Hospital Isel Bern

Bern, 3010, Switzerland

Location

Universitätsspital Zürich

Zurich, 8091, Switzerland

Location

Brighton and Sussex Hospital

Brighton, BN25BE, United Kingdom

Location

Leeds General Infirmary

Leeds, LS13EX, United Kingdom

Location

Leicester Hospital

Leicester, Le3 9 QP, United Kingdom

Location

St. George's Hospital

London, SW170QT, United Kingdom

Location

The Heart Hospital

London, W1G8PH, United Kingdom

Location

Newcross Hospital Wolverhampton

Wolverhampton, WV10 OEN, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 28633375 DERIVED

• 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.

  PMID: 28484830 DERIVED

• 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.

  PMID: 26892451 DERIVED

• 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.

  PMID: 26762727 DERIVED

• 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.

  PMID: 26184612 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Results Point of Contact

• Title: Hanne Gonnissen
• Organization: Medronic Bakken Research Center

hanne.gonnissen@medtronic.com

+3143356

Study Officials

• Axel Linke, Prof Dr med

  Universitat Leipzig Herzzentrum

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2010
• First Posted: February 24, 2010
• Study Start: March 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: May 1, 2017
• Last Updated: December 2, 2017
• Results First Posted: October 21, 2016

Record last verified: 2017-10

Locations

PT (2); GR (1); IL (3); FR (6); NL (4); CH (2); IT (8); GB (6); BE (3); CO (1); DK (1); DE (7)