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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 )

Tracking Information
First Submitted Date July 31, 2014
First Posted Date August 5, 2014
Last Update Posted Date April 16, 2019
Actual Study Start Date November 2014
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 27, 2017)
  • Cardiovascular death [ Time Frame: 30 days post-index procedure ]
  • Lack of significant aortic stenosis or insufficiency [ Time Frame: 1 year Follow-up ]
Original Primary Outcome Measures
 (submitted: August 1, 2014)
Cardiovascular death [ Time Frame: 30 days post-index procedure ]
Change History
Current Secondary Outcome Measures
 (submitted: October 27, 2017)
  • Safety composite endpoint based on VARC-II endpoint definitions [ Time Frame: 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 ]
Original Secondary Outcome Measures
 (submitted: August 1, 2014)
Lack of significant aortic stenosis or insufficiency [ Time Frame: 1 year Follow-up ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis.
Official Title Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis. A Prospective, Observational Post-market Study.
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 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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Aortic Valve Stenosis
Intervention 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.
Study Groups/Cohorts 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.
Intervention: Device: CoreValve Transcatheter Valve
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 15, 2018)
202
Original Estimated Enrollment
 (submitted: August 1, 2014)
200
Actual Study Completion Date December 3, 2018
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France,   Germany,   Israel,   Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT02209298
Other Study ID Numbers MED-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Medtronic Cardiovascular ( Medtronic Bakken Research Center )
Original Responsible Party Same as current
Current Study Sponsor Medtronic Bakken Research Center
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
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
PRS Account Medtronic Cardiovascular
Verification Date April 2019