CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis.

Completed

• Conditions: Aortic Valve Stenosis
• Interventions: Device: CoreValve Transcatheter Valve

• Registration Number: NCT02209298
• Lead Sponsor: Medtronic Bakken Research Center

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 Timeline

• Study First Submitted: 2014-07-31
• Study First Submitted QC: 2014-08-01
• Study First Posted: 2014-08-05
• Study Start: 2014-11
• Primary Completion: 2017-11
• Study Completion: 2018-12-03
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-15
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CoreValve Transcatheter Valve	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.

Primary Outcome Measures

Name	Time	Method
Lack of significant aortic stenosis or insufficiency	1 year Follow-up
Cardiovascular death	30 days post-index procedure

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (25)

CHU Brest; 🇫🇷 Brest, France

CHU Clermont; 🇫🇷 Clermont-Ferrand, France

Clinique Parly 2 Le Chesnay; 🇫🇷 Le Chesnay, France

CHU Lille; 🇫🇷 Lille, France

Hopital Jacques Cartier; 🇫🇷 Massy, France

CHU de Nantes; 🇫🇷 Nantes, France

HCL CHU Louis Pradel; 🇫🇷 Lyon, France

CHU Bordeaux; 🇫🇷 Pessac, France

CHU Rangueil Toulouse; 🇫🇷 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

Brescia Hospital; 🇮🇹 Brescia, Italy

Policlinico San Donato; 🇮🇹 Milano, Italy

Azienda Ospedaliero Universitaria Pisana; 🇮🇹 Pisa, Italy

CHU Mondor; 🇫🇷 Créteil, France

CHU La Timone; 🇫🇷 Marseille, France

CHU La Pitié Salpétrière; 🇫🇷 Paris, France

Clinique Pasteur; 🇫🇷 Toulouse, France

CHU Rennes; 🇫🇷 Rennes, France

Sheba Medical Center; 🇮🇱 Tel Hashomer, Israel