Brief Title
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.
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 Type
Observational
Primary Outcome
Major Adverse Cardiac & Cerebrovascular Events (MACCE)
Secondary Outcome
Percentage of Participants With Device Success
Condition
Severe Aortic Stenosis
Intervention
Medtronic CoreValve System
Study Arms / Comparison Groups
severe aortic valve stenosis
Description: elderly patients with severe aortic valve stenosis requiring treatment
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
1015
Start Date
March 2010
Completion Date
May 2017
Primary Completion Date
November 2011
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Axel Linke, Prof Dr med, ,
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT01074658
Organization ID
Advance
Responsible Party
Sponsor
Study Sponsor
Medtronic Bakken Research Center
Study Sponsor
Axel Linke, Prof Dr med, Principal Investigator, Universitat Leipzig Herzzentrum
Verification Date
October 2017