CoreValve Advance International Post Market Study

Completed

• Conditions: Severe Aortic Stenosis
• Interventions: Device: Medtronic CoreValve System

• Registration Number: NCT01074658
• Lead Sponsor: Medtronic Bakken Research Center

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.

Study Timeline

• Study First Submitted: 2010-02-23
• Study First Submitted QC: 2010-02-23
• Study First Posted: 2010-02-24
• Study Start: 2010-03
• Primary Completion: 2011-11
• Results First Submitted: 2016-07-13
• Results First Submitted QC: 2016-08-30
• Results First Posted: 2016-10-21
• Study Completion: 2017-05
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-25
• Last Update Posted: 2017-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1015

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
severe aortic valve stenosis	Medtronic CoreValve System	elderly patients with severe aortic valve stenosis requiring treatment

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiac & Cerebrovascular Events (MACCE)	30 days	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Procedural Success	up to 30 days	Procedural success, defined as device success with absence of in-hospital MACCE
Percentage of Participants With Device Success	up to 24 hours	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

Trial Locations

Locations (44)

Hospital de Santa Cruz; 🇵🇹 Lisbon, Portugal

Centro Hospitalar de Vila Nova de Gaia; 🇵🇹 Porto, Portugal

Hopital Cardiologique; 🇫🇷 Lille, France

Azienda Ospedaliere Spedali Civili di Brescia; 🇮🇹 Brescia, Italy

Antwerpen UZA; 🇧🇪 Antwerp, Belgium

Amphia Breda; 🇳🇱 Breda, Netherlands

ZNA Antwerpen Middelheim; 🇧🇪 Antwerpen, Belgium

Universitätsklinikum Aachen; 🇩🇪 Aachen, Germany

CHU Sart Tillman; 🇧🇪 Liege, Belgium

Brighton and Sussex Hospital; 🇬🇧 Brighton, United Kingdom

Angiografia de Occidente; 🇨🇴 Cali, Colombia

St. Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Hopital Henri Mondor; 🇫🇷 Creteil, France

AMC Ziekenhuis; 🇳🇱 Amsterdam, Netherlands

Universtiy Hospital Isel Bern; 🇨🇭 Bern, Switzerland

CardioVascular Center Frankfurt; 🇩🇪 Frankfurt, Germany

Ospedale Civile; 🇮🇹 Legnano, Italy

Catharina Hospital; 🇳🇱 Eindhoven, Netherlands

Institut Hospitalier Jacques Cartier; 🇫🇷 Massy, France

Newcross Hospital Wolverhampton; 🇬🇧 Wolverhampton, United Kingdom

Ospedale Niguarda Ca'Granda; 🇮🇹 Milano, Italy

Fondazione Centro San Raffaele; 🇮🇹 Milano, Italy

Istituto Clinico S.Ambrogio; 🇮🇹 Milano, Italy

St. George's Hospital; 🇬🇧 London, United Kingdom

Universitätsspital Zürich; 🇨🇭 Zurich, Switzerland

The Heart Hospital; 🇬🇧 London, United Kingdom

Leeds General Infirmary; 🇬🇧 Leeds, United Kingdom

Leicester Hospital; 🇬🇧 Leicester, United Kingdom

Hopital Louis Pradel; 🇫🇷 Lyon, France

Groupe Hospitalier Pitie-Salpetriere; 🇫🇷 Paris Cedex, France

Clinique Pasteur; 🇫🇷 Toulouse Cedex, France

Universitat Leipzig Herzzentrum; 🇩🇪 Leipzig, Germany

Sheba Medical Center; 🇮🇱 Tel Aviv, Israel

Helios Herzzentrum Siegburg Gmbh; 🇩🇪 Siegburg, Germany

Hadassah Medical Center; 🇮🇱 Jerusalem, Israel

Deutsches Herzzentrum Munchen; 🇩🇪 Munchen, Germany

Istituto Clinico Humanitas; 🇮🇹 Rozzano, Italy

Asklepios Klinik St. Georg Hamburg; 🇩🇪 Hamburg, Germany

Azienda Ospedaliero-Universitaria Careggi; 🇮🇹 Firenze, Italy

Bernau Herzzentrum Brandenburg; 🇩🇪 Bernau b. Berlin, Germany

Onassis cardiac surgery center; 🇬🇷 Athens, Greece

Policlinico Vittorio Emanuele, P.O. Ferrarotto; 🇮🇹 Catania, Italy

Ichilov Medical Center; 🇮🇱 Tel Aviv, Israel