ClinicalTrials.gov

History of Changes for Study: NCT02209298
CoreValve VIVA Study
Latest version (submitted April 15, 2019) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 August 1, 2014 None (earliest Version on record)
2 September 29, 2015 Recruitment Status, Study Status, Groups and Interventions, Study Identification, Contacts/Locations, Study Description and Oversight
3 October 26, 2015 Contacts/Locations and Study Status
4 December 1, 2015 Study Status and Contacts/Locations
5 January 25, 2016 Contacts/Locations and Study Status
6 February 29, 2016 Contacts/Locations and Study Status
7 March 25, 2016 Contacts/Locations and Study Status
8 April 19, 2016 Study Status
9 July 6, 2016 Study Status and Contacts/Locations
10 September 27, 2016 Study Status and Contacts/Locations
11 October 10, 2016 Contacts/Locations and Study Status
12 October 11, 2016 Contacts/Locations and Study Status
13 November 9, 2016 Recruitment Status, Study Status, Contacts/Locations and Study Design
14 April 17, 2017 Study Status
15 October 27, 2017 Study Status and Outcome Measures
16 February 15, 2018 Study Status
17 April 10, 2018 Study Status
18 October 15, 2018 Study Status and Study Design
19 April 15, 2019 Recruitment Status and Study Status
Comparison Format:

Scroll up to access the controls

Study NCT02209298
Submitted Date:  August 1, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: MED-02
Brief Title: CoreValve VIVA Study
Official Title:
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2014
Overall Status: Not yet recruiting
Study Start: November 2014
Primary Completion: July 2018 [Anticipated]
Study Completion:
First Submitted: July 31, 2014
First Submitted that
Met QC Criteria:
August 1, 2014
First Posted: August 5, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
August 1, 2014
Last Update Posted: August 5, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Medtronic Bakken Research Center
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Aortic Valve Stenosis
Keywords:
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 200 [Anticipated]
Number of Groups/Cohorts 1
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
CoreValve implantation
Device: CoreValve Transcatheter Valve
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Cardiovascular death
[ Time Frame: 30 days post-index procedure ]

Secondary Outcome Measures:
1. Lack of significant aortic stenosis or insufficiency
[ Time Frame: 1 year Follow-up ]

Open or close this module Eligibility
Study Population: Subjects will be screened from symptomatic high risk adult patients candidates for an intervention on degenerative surgical aortic bioprosthesis.
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services