Brief Title
ADVANCE Direct Aortic Study
Official Title
CoreValve® ADVANCE Direct Aortic Study
Brief Summary
This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic access (DA) is selected.
Detailed Description
This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve stenosis for which treatment via direct aortic access (DA) is selected. As part of the study analysis, resource utilization together with the Quality of Life questionnaires data will provide an important input into cost effectiveness analysis.
Study Type
Observational
Primary Outcome
All-cause Mortality
Secondary Outcome
Kaplan-Meier Estimate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Condition
Aortic Stenosis
Intervention
CoreValve aortic valve
Study Arms / Comparison Groups
CoreValve aortic valve
Description: Implantation of CoreValve aortic valve via direct aortic approach
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
100
Start Date
September 2012
Completion Date
August 2015
Primary Completion Date
April 2014
Eligibility Criteria
Inclusion Criteria: 1. Severe symptomatic aortic valve stenosis requiring treatment 2. Acceptable candidate for elective treatment with the Medtronic CoreValve® System according to the most recent version of the Medtronic CoreValve® Instructions For Use 3. 21 years of age or older 4. Patient is willing and able to comply with all protocol-specified follow-up evaluations 5. 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") 6. Patient will receive the CoreValve® device via direct aortic approach TAVI - Exclusion Criteria: 1. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated 2. Sepsis, including active endocarditis 3. Recent myocardial infarction (<30 days) 4. Left ventricular or atrial thrombus by echocardiography 5. Uncontrolled atrial fibrillation 6. Mitral or tricuspid valvular insufficiency (>grade II) 7. Previous aortic valve replacement (mechanical valve or stented bioprosthetic valve) 8. Evolutive or recent (within 6 months of implant procedure) cerebrovascular accident (CVA) or transient ischemic attack (TIA) 9. Patients with: 1. Vascular conditions that make insertion and endovascular access to the aortic valve impossible, or 2. Symptomatic carotid or vertebral arterial narrowing (>70%) disease, or 3. Thoracic aortic aneurysm in the path of delivery system 10. Bleeding diathesis or coagulopathy 11. Patient refuses blood transfusion 12. Estimated life expectancy of less than 12 months unless TAVI is performed 13. Creatine clearance <20 mL/min 14. Active gastritis or peptic ulcer disease 15. Pregnancy or intent to become pregnant during study follow up 16. Patient is participating in another trial that may influence the results of this study -
Gender
All
Ages
21 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Neil Moat, M.D., ,
Location Countries
Czechia
Location Countries
Czechia
Administrative Informations
NCT ID
NCT01676727
Organization ID
Advance-DA
Responsible Party
Sponsor
Study Sponsor
Medtronic Bakken Research Center
Study Sponsor
Neil Moat, M.D., Principal Investigator, The Royal Brompton Hospital
Verification Date
August 2018