Clinical trial NCT01074658: CoreValve Advance International Post Market Study
Official title: CoreValve Advance International Post Market Study: Evaluation of the Medtronic CoreValve System in a "Real-World" Patient Population.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Aortic Stenosis
Keywords: Advance
Medtronic CoreValve System
International
Interventional
Post Market Study
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2010-02-24
Enrollment: 1015
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Major Adverse Cardiac & Cerebrovascular Events (MACCE)
timeFrame: 30 days
Secondary outcomes:
measure: Percentage of Participants With Device Success
timeFrame: up to 24 hours
measure: Percentage of Participants With Procedural Success
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: ZNA Antwerpen Middelheim
city: Antwerp
country: Belgium
facility: Antwerpen UZA
city: Liege
country: Belgium
facility: CHU Sart Tillman
city: Cali
country: Colombia
facility: Angiografia de Occidente
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Creteil
country: France
facility: Hopital Henri Mondor
city: Lille
country: France
facility: Hopital Cardiologique
city: Lyon
country: France
facility: Hopital Louis Pradel
city: Massy
country: France
facility: Institut Hospitalier Jacques Cartier
city: Paris Cedex
country: France
facility: Groupe Hospitalier Pitie-Salpetriere
city: Toulouse Cedex
country: France
facility: Clinique Pasteur
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen
city: Bernau b. Berlin
country: Germany
facility: Bernau Herzzentrum Brandenburg
city: Frankfurt
country: Germany
facility: CardioVascular Center Frankfurt
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg Hamburg
city: Leipzig
country: Germany
facility: Universitat Leipzig Herzzentrum
city: Munchen
country: Germany
facility: Deutsches Herzzentrum Munchen
city: Siegburg
country: Germany
facility: Helios Herzzentrum Siegburg Gmbh
city: Athens
country: Greece
facility: Onassis cardiac surgery center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Tel Aviv
country: Israel
facility: Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Ichilov Medical Center
city: Brescia
country: Italy
facility: Azienda Ospedaliere Spedali Civili di Brescia
city: Catania
country: Italy
facility: Policlinico Vittorio Emanuele, P.O. Ferrarotto
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
city: Legnano
country: Italy
facility: Ospedale Civile
city: Milano
country: Italy
facility: Ospedale Niguarda Ca'Granda
city: Milano
country: Italy
facility: Fondazione Centro San Raffaele
city: Milano
country: Italy
facility: Istituto Clinico S.Ambrogio
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Amsterdam
country: Netherlands
facility: AMC Ziekenhuis
city: Breda
country: Netherlands
facility: Amphia Breda
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Lisbon
country: Portugal
facility: Hospital de Santa Cruz
city: Porto
country: Portugal
facility: Centro Hospitalar de Vila Nova de Gaia
city: Bern
country: Switzerland
facility: Universtiy Hospital Isel Bern
city: Zurich
country: Switzerland
facility: Universitätsspital Zürich
city: Brighton
country: United Kingdom
facility: Brighton and Sussex Hospital
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: Leicester
country: United Kingdom
facility: Leicester Hospital
city: London
country: United Kingdom
facility: St. George's Hospital
city: London
country: United Kingdom
facility: The Heart Hospital
city: Wolverhampton
country: United Kingdom
facility: Newcross Hospital Wolverhampton
Study officials:
affiliation: Universitat Leipzig Herzzentrum
name: Axel Linke, Prof Dr med
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.