CoreValve Advance International Post Market Study

October 25, 2017 updated by: Medtronic Bakken Research Center

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1015

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium, 2650
        • Antwerpen UZA
      • Antwerpen, Belgium, 2020
        • ZNA Antwerpen Middelheim
      • Liege, Belgium, 4000
        • CHU Sart Tillman
  • Colombia
      • Cali, Colombia
        • Angiografia de Occidente
  • Denmark
      • Copenhagen, Denmark, DK2100
        • Rigshospitalet
  • France
      • Creteil, France, 94010
        • Hopital Henri Mondor
      • Lille, France, 59037
        • Hôpital Cardiologique
      • Lyon, France, 69677
        • Hôpital Louis Pradel
      • Massy, France, 91300
        • Institut Hospitalier Jacques Cartier
      • Paris Cedex, France, 75013
        • Groupe Hospitalier Pitie-Salpetriere
      • Toulouse Cedex, France, 31076
        • Clinique Pasteur
  • Germany
      • Aachen, Germany, 52057
        • Universitätsklinikum Aachen
      • Bernau b. Berlin, Germany, 16321
        • Bernau Herzzentrum Brandenburg
      • Frankfurt, Germany, 60389
        • Cardiovascular center Frankfurt
      • Hamburg, Germany, 20099
        • Asklepios Klinik St. Georg Hamburg
      • Leipzig, Germany, 04289
        • Universität Leipzig Herzzentrum
      • Munchen, Germany, 80636
        • Deutsches Herzzentrum München
      • Siegburg, Germany, 53721
        • Helios Herzzentrum Siegburg Gmbh
  • Greece
      • Athens, Greece, 17674
        • Onassis Cardiac Surgery Center
  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah Medical Center
      • Tel Aviv, Israel, 52621
        • Sheba Medical Center
      • Tel Aviv, Israel, 64239
        • Ichilov Medical Center
  • Italy
      • Brescia, Italy, 25123
        • Azienda Ospedaliere Spedali Civili di Brescia
      • Catania, Italy, 95024
        • Policlinico Vittorio Emanuele, P.O. Ferrarotto
      • Firenze, Italy, 50134
        • Azienda Ospedaliero-Universitaria Careggi
      • Legnano, Italy
        • Ospedale Civile
      • Milano, Italy
        • Istituto Clinico S.Ambrogio
      • Milano, Italy, 20025
        • Ospedale Niguarda Ca'Granda
      • Milano, Italy
        • Fondazione Centro San Raffaele
      • Rozzano, Italy, 20089
        • Istituto Clinico Humanitas
  • Netherlands
      • Amsterdam, Netherlands, 1100 DD
        • AMC Ziekenhuis
      • Breda, Netherlands, 4818 CK
        • Amphia Breda
      • Eindhoven, Netherlands, 5623 EJ
        • Catharina Hospital
      • Nieuwegein, Netherlands, 3435 CM
        • St. Antonius Ziekenhuis
  • Portugal
      • Lisbon, Portugal, 2799-523
        • Hospital de Santa Cruz
      • Porto, Portugal, 4400
        • Centro Hospitalar de Vila Nova de Gaia
  • Switzerland
      • Bern, Switzerland, 3010
        • Universtiy Hospital Isel Bern
      • Zurich, Switzerland, 8091
        • Universitatsspital Zurich
  • United Kingdom
      • Brighton, United Kingdom, BN25BE
        • Brighton and Sussex Hospital
      • Leeds, United Kingdom, LS13EX
        • Leeds General Infirmary
      • Leicester, United Kingdom, Le3 9 QP
        • Leicester Hospital
      • London, United Kingdom, SW170QT
        • St. George's Hospital
      • London, United Kingdom, W1G8PH
        • The Heart Hospital
      • Wolverhampton, United Kingdom, WV10 OEN
        • Newcross Hospital Wolverhampton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
up to 24 hours
Percentage of Participants With Procedural Success
Time Frame: up to 30 days
Procedural success, defined as device success with absence of in-hospital MACCE
up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic Bakken Research Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Axel Linke, Prof Dr med, Universität Leipzig Herzzentrum

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ADVANCE (European Commission)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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