Brief Title
CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis.
Official Title
Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis. A Prospective, Observational Post-market Study.
Brief Summary
This observational study is intended to collect real-world (post-approval use) data regarding the clinical utility and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI).
Detailed Description
To collect real-world (post-approval use) data regarding the clinical utility and performance of the Medtronic CoreValve® System for TAVI in patients with failing surgical aortic bioprosthesis who are at high risk for redo surgery.
Study Type
Observational
Primary Outcome
Cardiovascular death
Secondary Outcome
Safety composite endpoint based on VARC-II endpoint definitions
Condition
Aortic Valve Stenosis
Intervention
CoreValve Transcatheter Valve
Study Arms / Comparison Groups
CoreValve Transcatheter Valve
Description: Medtronic CoreValve SystemTM is designed to replace the native or surgical bioprosthetic aortic heart valve without open heart surgery and without concomitant surgical removal of the failing valve. The support frame is manufactured by Nitinol, which has multi-level, self-expanding properties and is radiopaque. The bioprosthesis is manufactured by suturing valve leaflets and a skirt from a single layer of porcine pericardium into a tri-leaflet configuration. The bioprosthesis is processed with alpha-amino oleic acid (AOA™), which is a compound derived from oleic acid, a naturally occurring long-chain fatty acid. AOA™ is an antimineralization treatment shown to reduce both early and late valvular calcification.
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
202
Start Date
November 2014
Completion Date
December 3, 2018
Primary Completion Date
November 2017
Eligibility Criteria
Inclusion Criteria: - Patient is > 18 years old - Patient has a symptomatic degeneration of aortic bioprosthesis - Acceptable candidate for elective treatment with the Medtronic CoreValveTM System (according to the most recent version of the Medtronic CoreValveTM Instructions For Use) and in conformity with the local regulatory and reimbursement context - Logistical Euroscore > 20% or STS > 10% or presence of comorbidities responsible of contra-indication(s) for redo surgery as assessed by at least one cardiac surgeon or patients in whom heart team has assessed the redo surgery at high risk - The patient or legal representative has been informed of the nature of the procedure and 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") - The patient is willing and able to comply with requirements of the study, including the 24 months follow-up - Patient will receive the CoreValveTM device in a degenerated surgical bioprosthesis Exclusion Criteria: - Patients in whom anti-platelet and/or anticoagulant therapy is contraindicated - Patient in whom heart team considers that risk of TAVI is too high with a particular attention for the risk of coronary occlusion - Patient with prior endocarditis on failed bioprosthesis - Patient has other medical illness associated with a limited life expectancy (i.e., less than 1 year) - Patient with LVEF <20%, cardiogenic shock, or hemodynamic compromise requiring pressors or inotropes or mechanical support devices - Patient with severe mitral disease associated with severe pulmonary hypertension - Acute coronary syndrome less than 7 days before intervention - Currently participating in another investigational drug or device study. - Patient with significant paravalvular regurgitation - Patient in whom internal diameter prosthesis is equal to 17 mm
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Didier Tchetche, Dr., ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT02209298
Organization ID
MED-02
Responsible Party
Sponsor
Study Sponsor
Medtronic Bakken Research Center
Study Sponsor
Didier Tchetche, Dr., Principal Investigator, Clinique Pasteur Toulouse
Verification Date
April 2019