CoreValve Advance International Post Market Study

CoreValve Advance International Post Market Study: Evaluation of the Medtronic CoreValve System in a "Real-World" Patient Population.

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

Study Overview

• Status: Completed
• Conditions: Severe Aortic Stenosis
• Intervention / Treatment: Device: Medtronic CoreValve System

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.

• Study Type: Observational
• Enrollment (Actual): 1015

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2650
    • Antwerpen UZA
  • Antwerpen, Belgium, 2020
    • ZNA Antwerpen Middelheim
  • Liege, Belgium, 4000
    • CHU Sart Tillman
• Colombia
  • Cali, Colombia
    • Angiografia de Occidente
• Denmark
  • Copenhagen, Denmark, DK2100
    • Rigshospitalet
• France
  • Creteil, France, 94010
    • Hôpital Henri Mondor
  • Lille, France, 59037
    • Hopital Cardiologique
  • Lyon, France, 69677
    • Hôpital Louis Pradel
  • Massy, France, 91300
    • Institut Hospitalier Jacques Cartier
  • Paris Cedex, France, 75013
    • Groupe Hospitalier Pitie-Salpetriere
  • Toulouse Cedex, France, 31076
    • Clinique Pasteur
• Germany
  • Aachen, Germany, 52057
    • Universitätsklinikum Aachen
  • Bernau b. Berlin, Germany, 16321
    • Bernau Herzzentrum Brandenburg
  • Frankfurt, Germany, 60389
    • Cardiovascular Center Frankfurt
  • Hamburg, Germany, 20099
    • Asklepios Klinik St. Georg Hamburg
  • Leipzig, Germany, 04289
    • Universität Leipzig Herzzentrum
  • Munchen, Germany, 80636
    • Deutsches Herzzentrum München
  • Siegburg, Germany, 53721
    • Helios Herzzentrum Siegburg Gmbh
• Greece
  • Athens, Greece, 17674
    • Onassis Cardiac Surgery Center
• Israel
  • Jerusalem, Israel, 91120
    • Hadassah Medical Center
  • Tel Aviv, Israel, 52621
    • Sheba Medical Center
  • Tel Aviv, Israel, 64239
    • Ichilov Medical Center
• Italy
  • Brescia, Italy, 25123
    • Azienda Ospedaliere Spedali Civili di Brescia
  • Catania, Italy, 95024
    • Policlinico Vittorio Emanuele, P.O. Ferrarotto
  • Firenze, Italy, 50134
    • Azienda Ospedaliero-Universitaria Careggi
  • Legnano, Italy
    • Ospedale Civile
  • Milano, Italy
    • Istituto Clinico S.Ambrogio
  • Milano, Italy, 20025
    • Ospedale Niguarda Ca'Granda
  • Milano, Italy
    • Fondazione Centro San Raffaele
  • Rozzano, Italy, 20089
    • Istituto Clinico Humanitas
• Netherlands
  • Amsterdam, Netherlands, 1100 DD
    • AMC Ziekenhuis
  • Breda, Netherlands, 4818 CK
    • Amphia Breda
  • Eindhoven, Netherlands, 5623 EJ
    • Catharina Hospital
  • Nieuwegein, Netherlands, 3435 CM
    • St. Antonius Ziekenhuis
• Portugal
  • Lisbon, Portugal, 2799-523
    • Hospital de Santa Cruz
  • Porto, Portugal, 4400
    • Centro Hospitalar de Vila Nova de Gaia
• Switzerland
  • Bern, Switzerland, 3010
    • Universtiy Hospital Isel Bern
  • Zurich, Switzerland, 8091
    • Universitatsspital Zurich
• United Kingdom
  • Brighton, United Kingdom, BN25BE
    • Brighton and Sussex Hospital
  • Leeds, United Kingdom, LS13EX
    • Leeds General Infirmary
  • Leicester, United Kingdom, Le3 9 QP
    • Leicester Hospital
  • London, United Kingdom, SW170QT
    • St. George's Hospital
  • London, United Kingdom, W1G8PH
    • The Heart Hospital
  • Wolverhampton, United Kingdom, WV10 OEN
    • Newcross Hospital Wolverhampton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
severe aortic valve stenosis; elderly patients with severe aortic valve stenosis requiring treatment	Device: Medtronic CoreValve System; Transcatheter Aortic Valve Implantation of the Medtronic CoreValve System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Device Success	Device Success is defined as a composite of: Successful device delivery;; Stable device placement;; Intact retrieval of delivery catheter;; Successful device function as assessed immediately post-procedure by angiography including non-compromised flow in coronary arteries (without obstruction) device position (no migration) and a mean gradient as determined invasively of <15mmHg and ≤ 2 aortic regurgitation	up to 24 hours
Percentage of Participants With Procedural Success	Procedural success, defined as device success with absence of in-hospital MACCE	up to 30 days

Collaborators and Investigators

• Sponsor: Medtronic Bakken Research Center
• Investigators: Principal Investigator: Axel Linke, Prof Dr med, Universität Leipzig Herzzentrum

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Clin Res Cardiol. 2017 Jul 4;:
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: February 23, 2010
• First Submitted That Met QC Criteria: February 23, 2010
• First Posted (Estimate): February 24, 2010

Study Record Updates

• Last Update Posted (Actual): December 2, 2017
• Last Update Submitted That Met QC Criteria: October 25, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Interventional; International; Advance; Medtronic CoreValve System; Post Market Study
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: ADVANCE