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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CoreValve Transcatheter Valve | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CoreValve Transcatheter Valve | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular death | 30 days post-index procedure | |
| Lack of significant aortic stenosis or insufficiency | 1 year Follow-up |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be screened from symptomatic high risk adult patients candidates for an intervention on degenerative surgical aortic bioprosthesis.
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| Name | Affiliation | Role |
|---|---|---|
| Didier Tchetche, Dr. | Clinique Pasteur Toulouse | Principal Investigator |
| Jean-Philippe Verhoye, Prof. | Centre Hospitalier Universitaire, Rennes | Principal Investigator |
| Ran Kornowski, Prof. | Rabin Medical Center, Tel Aviv | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Brest | Brest | France | ||||
| CHU Clermont |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33383007 | Derived | Kornowski R, Chevalier B, Verhoye JP, Holzhey D, Harnath A, Schӓfer U, Teiger E, Manigold T, Modine T, Souteyrand G, Champagnac D, Oh JK, Li S, Tchetche D; VIVA Investigators. Transcatheter Aortic Valve Implantation for Failed Surgical Aortic Bioprostheses Using a Self-Expanding Device (from the Prospective VIVA Post Market Study). Am J Cardiol. 2021 Apr 1;144:118-124. doi: 10.1016/j.amjcard.2020.12.047. Epub 2020 Dec 28. | |
| 31122349 |
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|
| At 30 days and during follow-up visits |
| Clermont-Ferrand |
| France |
| CHU Mondor | Créteil | France |
| Clinique Parly 2 Le Chesnay | Le Chesnay | France |
| CHU Lille | Lille | France |
| HCL CHU Louis Pradel | Lyon | France |
| CHU La Timone | Marseille | France |
| Hopital Jacques Cartier | Massy | France |
| CHU de Nantes | Nantes | France |
| CHU La Pitié Salpétrière | Paris | France |
| CHU Bordeaux | Pessac | France |
| CHU Rennes | Rennes | France |
| CHU Rangueil Toulouse | Toulouse | France |
| Clinique Pasteur | Toulouse | France |
| Tonkin Clinic | Villeurbanne | France |
| Kerckhoff Klinik | Bad Nauheim | Germany |
| Herz- und Diabeteszentrum NRW | Bad Oeynhausen | Germany |
| Sana-Herzzentrum Cottbus | Cottbus | Germany |
| Hamburg Eppendorf | Hamburg | Germany |
| Herzzentrum Leipzig GmbH Leipzig | Leipzig | Germany |
| Rabin Medical center | Petah Tikva | Israel |
| Sheba Medical Center | Tel Litwinsky | Israel |
| Brescia Hospital | Brescia | Italy |
| Policlinico San Donato | Milan | Italy |
| Azienda Ospedaliero Universitaria Pisana | Pisa | Italy |
| Derived |
| Tchetche D, Chevalier B, Holzhey D, Harnath A, Schafer U, Teiger E, Manigold T, Modine T, Souteyrand G, Champagnac D, Oh JK, Li S, Verhoye JP, Kornowski R; VIVA Investigators. TAVR for Failed Surgical Aortic Bioprostheses Using a Self-Expanding Device: 1-Year Results From the Prospective VIVA Postmarket Study. JACC Cardiovasc Interv. 2019 May 27;12(10):923-932. doi: 10.1016/j.jcin.2019.02.029. |
| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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