Clinical trial NCT02209298: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2014-08-05
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be screened from symptomatic high risk adult patients candidates for an intervention on degenerative surgical aortic bioprosthesis.

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.

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

Primary outcomes:
measure: Cardiovascular death
timeFrame: 30 days post-index procedure
measure: Lack of significant aortic stenosis or insufficiency
timeFrame: 1 year Follow-up
Secondary outcomes:
measure: Safety composite endpoint based on VARC-II endpoint definitions
timeFrame: At 30 days and during follow-up visits
measure: 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
timeFrame: At 30 days and during follow-up visits
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU Brest
city: Clermont-Ferrand
country: France
facility: CHU Clermont
city: Créteil
country: France
facility: CHU Mondor
city: Le Chesnay
country: France
facility: Clinique Parly 2 Le Chesnay
city: Lille
country: France
facility: CHU Lille
city: Lyon
country: France
facility: HCL CHU Louis Pradel
city: Marseille
country: France
facility: CHU La Timone
city: Massy
country: France
facility: Hopital Jacques Cartier
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: CHU La Pitié Salpétrière
city: Pessac
country: France
facility: CHU Bordeaux
city: Rennes
country: France
facility: CHU Rennes
city: Toulouse
country: France
facility: CHU Rangueil Toulouse
city: Toulouse
country: France
facility: Clinique Pasteur
city: Villeurbanne
country: France
facility: Tonkin Clinic
city: Bad Nauheim
country: Germany
facility: Kerckhoff Klinik
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW
city: Cottbus
country: Germany
facility: Sana-Herzzentrum Cottbus
city: Hamburg
country: Germany
facility: Hamburg Eppendorf
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH Leipzig
city: Petah Tikva
country: Israel
facility: Rabin Medical center
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
city: Brescia
country: Italy
facility: Brescia Hospital
city: Milano
country: Italy
facility: Policlinico San Donato
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
Study officials:
affiliation: Clinique Pasteur Toulouse
name: Didier Tchetche, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier Universitaire, Rennes
name: Jean-Philippe Verhoye, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rabin Medical Center, Tel Aviv
name: Ran Kornowski, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.