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Aortic Valve StenosisNCT02209298

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

An observational study of Aortic Valve Stenosis, run by Medtronic Cardiac Rhythm and Heart Failure at 25 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Aortic Valve Stenosis
What is being tested?
CoreValve Transcatheter Valve
Type of treatment
Medical device
How many people
202 participants
Where
25 sitesin 4 countries
Study dates
Nov 2014to 3 Dec 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Subjects will be screened from symptomatic high risk adult patients candidates for an intervention on degenerative surgical aortic bioprosthesis.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

25 sites in 4 countries.

25 sites in 4 countries

France15 sites

  • CHU Brest

    Brest

  • CHU Clermont

    Clermont-Ferrand

  • CHU Mondor

    Créteil

  • Clinique Parly 2 Le Chesnay

    Le Chesnay

  • CHU Lille

    Lille

  • HCL CHU Louis Pradel

    Lyon

  • CHU La Timone

    Marseille

  • Hopital Jacques Cartier

    Massy

  • CHU de Nantes

    Nantes

  • CHU La Pitié Salpétrière

    Paris

  • CHU Bordeaux

    Pessac

  • CHU Rennes

    Rennes

  • CHU Rangueil Toulouse

    Toulouse

  • Clinique Pasteur

    Toulouse

  • Tonkin Clinic

    Villeurbanne

Other trials in France

Germany5 sites

  • Kerckhoff Klinik

    Bad Nauheim

  • Herz- und Diabeteszentrum NRW

    Bad Oeynhausen

  • Sana-Herzzentrum Cottbus

    Cottbus

  • Hamburg Eppendorf

    Hamburg

  • Herzzentrum Leipzig GmbH Leipzig

    Leipzig

Other trials in Germany

Italy3 sites

  • Brescia Hospital

    Brescia

  • Policlinico San Donato

    Milan

  • Azienda Ospedaliero Universitaria Pisana

    Pisa

Other trials in Italy

Israel2 sites

  • Rabin Medical center

    Petah Tikva

  • Sheba Medical Center

    Tel HaShomer

Other trials in Israel

About this study

Official title: 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).

Read the 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.

Being tested
CoreValve Transcatheter Valve
Medical subject headings
Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CoreValve Transcatheter ValveDevice

    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.

Study groups in NCT02209298
Study groupRoleWhat they receive
CoreValve Transcatheter ValveMedtronic 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.
Receives: Device: CoreValve Transcatheter Valve

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiovascular death

    Measured: 30 days post-index procedure

  2. Lack of significant aortic stenosis or insufficiency

    Measured: 1 year Follow-up

Secondary outcomes (2)

  1. Safety composite endpoint based on VARC-II endpoint definitions

    Measured: 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

    Measured: At 30 days and during follow-up visits

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionNov 2017
  4. Study completion3 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
202 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02209298
Sponsor's protocol ID
MED-02
Status last verified
Apr 2019
First submitted
31 Jul 2014
Last updated
16 Apr 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 33383007

  • 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.

    PubMed 31122349

Questions about this trial

What is this clinical trial studying?

An observational study of Aortic Valve Stenosis, run by Medtronic Cardiac Rhythm and Heart Failure at 25 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in France, Germany, Italy, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiovascular death (time frame: 30 days post-index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02209298, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.

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