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Completed

NCT Number: NCT01074658

CoreValve Advance International Post Market Study

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Antwerpen UZA, Antwerp, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medtronic CoreValve System

Device

Transcatheter Aortic Valve Implantation of the Medtronic CoreValve System

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Official study title

CoreValve Advance International Post Market Study: Evaluation of the Medtronic CoreValve System in a "Real-World" Patient Population.

Important dates

Study start
2010
Primary completion
2011
Study completion
2017
First posted
Feb 24, 2010
Registry last updated
Dec 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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