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CoreValve Advance International Post Market Study

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01074658
First Posted: February 24, 2010
Last Update Posted: May 30, 2017
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.
Information provided by (Responsible Party):
Medtronic Cardiovascular ( Medtronic Bakken Research Center )
  Purpose
The CoreValve Advance study is intended to evaluate the clinical utility of the Medtronic CoreValve System in a "Real-World" patient population.

Condition Intervention
Severe Aortic Stenosis Device: Medtronic CoreValve System

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiovascular ( Medtronic Bakken Research Center ):

Primary Outcome Measures:
  • 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:
  • 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

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


Enrollment: 1015
Study Start Date: March 2010
Estimated Study Completion Date: May 2017
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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


  Show 44 Study Locations
Sponsors and Collaborators
Medtronic Bakken Research Center
Investigators
Principal Investigator: Axel Linke, Prof Dr med Universitat Leipzig Herzzentrum
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01074658     History of Changes
Other Study ID Numbers: Advance
First Submitted: February 23, 2010
First Posted: February 24, 2010
Results First Submitted: July 13, 2016
Results First Posted: October 21, 2016
Last Update Posted: May 30, 2017
Last Verified: April 2017

Keywords provided by Medtronic Cardiovascular ( Medtronic Bakken Research Center ):
Advance
Medtronic CoreValve System
International
Interventional
Post Market Study

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction