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

April 15, 2019 updated by: Medtronic Bakken Research Center

Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis. A Prospective, Observational Post-market Study.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

202

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France
        • CHU Brest
      • Clermont-Ferrand, France
        • CHU Clermont
      • Créteil, France
        • CHU Mondor
      • Le Chesnay, France
        • Clinique Parly 2 Le Chesnay
      • Lille, France
        • CHU Lille
      • Lyon, France
        • HCL CHU Louis Pradel
      • Marseille, France
        • CHU La Timone
      • Massy, France
        • Hôpital Jacques Cartier
      • Nantes, France
        • CHU de Nantes
      • Paris, France
        • CHU La Pitié Salpêtrière
      • Pessac, France
        • CHU Bordeaux
      • Rennes, France
        • CHU Rennes
      • Toulouse, France
        • Clinique Pasteur
      • Toulouse, France
        • CHU Rangueil Toulouse
      • Villeurbanne, France
        • Tonkin Clinic
  • Germany
      • Bad Nauheim, Germany
        • Kerckhoff Klinik
      • Bad Oeynhausen, Germany
        • Herz- und Diabeteszentrum NRW
      • Cottbus, Germany
        • Sana-Herzzentrum Cottbus
      • Hamburg, Germany
        • Hamburg Eppendorf
      • Leipzig, Germany
        • Herzzentrum Leipzig GmbH Leipzig
  • Israel
      • Petah Tikva, Israel
        • Rabin Medical Center
      • Tel Hashomer, Israel
        • Sheba Medical Center
  • Italy
      • Brescia, Italy
        • Brescia Hospital
      • Milano, Italy
        • Policlínico San Donato
      • Pisa, Italy
        • Azienda Ospedaliero Universitaria Pisana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiovascular death
Time Frame: 30 days post-index procedure
30 days post-index procedure
Lack of significant aortic stenosis or insufficiency
Time Frame: 1 year Follow-up
1 year Follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety composite endpoint based on VARC-II endpoint definitions
Time Frame: At 30 days and during follow-up visits
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
Time Frame: At 30 days and during follow-up visits
At 30 days and during follow-up visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Bakken Research Center

Investigators

  • Principal Investigator: Didier Tchétché, 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

December 3, 2018

Study Registration Dates

First Submitted

July 31, 2014

First Submitted That Met QC Criteria

August 1, 2014

First Posted (Estimate)

August 5, 2014

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 15, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MED-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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