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

NCT02209298 | Completed DMC

• 1 other identifier: MED-02
• Study Type: observational
• Target: 202
• Locations: 4 countries
• Sites: 25

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).

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (2)

• Cardiovascular death

  30 days post-index procedure

• Lack of significant aortic stenosis or insufficiency

  1 year Follow-up

Secondary Outcomes (2)

• 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

Study Arms (1)

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.

Device: CoreValve Transcatheter Valve

Interventions

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.

CoreValve Transcatheter Valve

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (25)

CHU Brest

Brest, France

Location

CHU Clermont

Clermont-Ferrand, France

Location

CHU Mondor

Créteil, France

Location

Clinique Parly 2 Le Chesnay

Le Chesnay, France

Location

CHU Lille

Lille, France

Location

HCL CHU Louis Pradel

Lyon, France

Location

CHU La Timone

Marseille, France

Location

Hopital Jacques Cartier

Massy, France

Location

CHU de Nantes

Nantes, France

Location

CHU La Pitié Salpétrière

Paris, France

Location

CHU Bordeaux

Pessac, France

Location

CHU Rennes

Rennes, France

Location

CHU Rangueil Toulouse

Toulouse, France

Location

Clinique Pasteur

Toulouse, France

Location

Tonkin Clinic

Villeurbanne, France

Location

Kerckhoff Klinik

Bad Nauheim, Germany

Location

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, Germany

Location

Sana-Herzzentrum Cottbus

Cottbus, Germany

Location

Hamburg Eppendorf

Hamburg, Germany

Location

Herzzentrum Leipzig GmbH Leipzig

Leipzig, Germany

Location

Rabin Medical center

Petah Tikva, Israel

Location

Sheba Medical Center

Tel Litwinsky, Israel

Location

Brescia Hospital

Brescia, Italy

Location

Policlinico San Donato

Milan, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Location

Related Publications (2)

• 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.

  PMID: 33383007 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.

  PMID: 31122349 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: August 5, 2014
• Study Start: November 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: December 3, 2018
• Last Updated: April 16, 2019

Record last verified: 2019-04

Locations

IT (3); DE (5); FR (15); IL (2)