CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis.
NCT ID: NCT02209298
Last Updated: 2019-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
202 participants
OBSERVATIONAL
2014-11-30
2018-12-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
CoreValve 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.
Interventions
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CoreValve 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Principal Investigators
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Didier Tchetche, Dr.
Role: PRINCIPAL_INVESTIGATOR
Clinique Pasteur Toulouse
Jean-Philippe Verhoye, Prof.
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire, Rennes
Ran Kornowski, Prof.
Role: PRINCIPAL_INVESTIGATOR
Rabin Medical Center, Tel Aviv
Locations
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CHU Brest
Brest, , France
CHU Clermont
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
Countries
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References
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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.
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.
Other Identifiers
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MED-02
Identifier Type: -
Identifier Source: org_study_id
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