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

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ClinicalTrials.gov Identifier: NCT02209298
Recruitment Status : Completed
First Posted : August 5, 2014
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular ( 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).

Condition or disease Intervention/treatment
Aortic Valve Stenosis Device: CoreValve Transcatheter Valve

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.

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Study Type : Observational
Actual Enrollment : 202 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis. A Prospective, Observational Post-market Study.
Actual Study Start Date : November 2014
Actual Primary Completion Date : November 2017
Actual Study Completion Date : December 3, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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.




Primary Outcome Measures :
  1. Cardiovascular death [ Time Frame: 30 days post-index procedure ]
  2. Lack of significant aortic stenosis or insufficiency [ Time Frame: 1 year Follow-up ]

Secondary Outcome Measures :
  1. Safety composite endpoint based on VARC-II endpoint definitions [ Time Frame: At 30 days and during follow-up visits ]
  2. 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 [ Time Frame: At 30 days and during follow-up visits ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02209298


Locations
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France
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
Germany
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
Israel
Rabin Medical center
Petah Tikva, Israel
Sheba Medical Center
Tel Hashomer, Israel
Italy
Brescia Hospital
Brescia, Italy
Policlinico San Donato
Milano, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Sponsors and Collaborators
Medtronic Bakken Research Center
Investigators
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Principal Investigator: 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT02209298     History of Changes
Other Study ID Numbers: MED-02
First Posted: August 5, 2014    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction