Aortic Valve Stenosis
Conditions
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.
Interventions
DEVICECoreValve Transcatheter Valve
Patients should be accepted for TAVI by a multidisciplinary team. The procedure should use the Medtronic CoreValve SystemTM and point of enrolment is the day of the procedure. The choice of prosthesis size and access route (transfemoral, subclavian or direct aortic access) is to be left to the discretion of the operating team. Equally the intraprocedural details (anaesthetic, imaging etc.) will proceed as per usual practice.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiovascular death | 30 days post-index procedure |
| Lack of significant aortic stenosis or insufficiency | 1 year Follow-up |
Secondary
| Measure | Time frame |
|---|---|
| Safety composite endpoint based on VARC-II endpoint definitions | At 30 days and during follow-up visits |
| Peri-procedural myocardial infarction, major and minor access site complications, major bleeding, stroke, acute kidney injury stage III, new pacemaker implantation, and post-implantation aortic gradient | At 30 days and during follow-up visits |
Countries
France, Germany, Israel, Italy
Outcome results
None listed