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CoreValve Advance International Post Market Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01074658
Recruitment Status : Completed
First Posted : February 24, 2010
Results First Posted : October 21, 2016
Last Update Posted : December 2, 2017
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular ( Medtronic Bakken Research Center )

Study Description
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Brief Summary:
The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic CoreValve System in a "Real-World" patient population.

Condition or disease Intervention/treatment
Severe Aortic Stenosis Device: Medtronic CoreValve System

Detailed Description:
The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic CoreValve System for percutaneous aortic valve implantation in a "Real-World" patient population with severe aortic valve stenosis. Data collected in this study will provide additional information on the understanding of the safety and device performance and how to best treat elderly patients with severe aortic valve stenosis. In addition, health economic data will be collected to understand the improvement of quality of life and the cost effectiveness of the therapy.
Study Design
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Study Type : Observational
Actual Enrollment : 1015 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: CoreValve Advance International Post Market Study: Evaluation of the Medtronic CoreValve System in a "Real-World" Patient Population.
Study Start Date : March 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
severe aortic valve stenosis
elderly patients with severe aortic valve stenosis requiring treatment
 Device: Medtronic CoreValve System
Transcatheter Aortic Valve Implantation of the Medtronic CoreValve System


Outcome Measures
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Primary Outcome Measures :
  1. Major Adverse Cardiac & Cerebrovascular Events (MACCE) [ Time Frame: 30 days ]

    MACCE is defined as a composite of:

    • All cause mortality
    • Myocardial Infarction (Q-wave and non-Q-wave)
    • Emergent cardiac surgery or percutaneous re-intervention
    • Stroke

    The Kaplan-Meier survival analysis was used to derive the freedom from MACCE at 30 days.



Secondary Outcome Measures :
  1. Percentage of Participants With Device Success [ Time Frame: up to 24 hours ]

    Device Success is defined as a composite of:

    • Successful device delivery;
    • Stable device placement;
    • Intact retrieval of delivery catheter;
    • Successful device function as assessed immediately post-procedure by angiography including non-compromised flow in coronary arteries (without obstruction) device position (no migration) and a mean gradient as determined invasively of <15mmHg and ≤ 2 aortic regurgitation

  2. Percentage of Participants With Procedural Success [ Time Frame: up to 30 days ]
    Procedural success, defined as device success with absence of in-hospital MACCE


Eligibility Criteria
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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
patients with severe aortic valve stenosis requiring treatment, who are selected to be treated electively with the Medtronic CoreValve System
Criteria

Inclusion Criteria:

  • Patients with severe aortic valve stenosis requiring treatment
  • Patient is an acceptable candidate for elective treatment with the Medtronic CoreValve System and in conformity with the local regulatory and medico economical context
  • Patient is above the minimum age as required by local regulations to be participating in a clinical study
  • The patient or legal representative has been informed of the nature of 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")

Exclusion Criteria:

  • Currently participating in another trial
  • High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
  • Pregnancy
Contacts and Locations
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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): NCT01074658


Locations
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Sponsors and Collaborators
Medtronic Bakken Research Center
Investigators
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Principal Investigator: Axel Linke, Prof Dr med Universitat Leipzig Herzzentrum
More Information
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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: NCT01074658    
Other Study ID Numbers: Advance
First Posted: February 24, 2010    Key Record Dates
Results First Posted: October 21, 2016
Last Update Posted: December 2, 2017
Last Verified: October 2017
Keywords provided by Medtronic Cardiovascular ( Medtronic Bakken Research Center ):
Advance
Medtronic CoreValve System
International
Interventional
Post Market Study
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases
 Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction