CoreValve Advance International Post Market Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT01074658
First received: February 23, 2010
Last updated: June 28, 2014
Last verified: June 2014
  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 Phase
Severe Aortic Stenosis
Device: Medtronic CoreValve System
Phase 4

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 Bakken Research Center:

Primary Outcome Measures:
  • Major Adverse Cardiac & Cerebrovascular Events (MACCE) [ Time Frame: 30 days post procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Device success [ Time Frame: Procedure ] [ Designated as safety issue: No ]
  • Procedural success [ Time Frame: In-hospital stay ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: March 2010
Estimated Study Completion Date: December 2016
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01074658     History of Changes
Other Study ID Numbers: Advance
Study First Received: February 23, 2010
Last Updated: June 28, 2014
Health Authority: Austria: Agency for Health and Food Safety
Germany: Federal Institute for Drugs and Medical Devices
Belgium: Institutional Review Board
Denmark: Ethics Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Greece: Ministry of Public Health and Social Assistance
Israel: Ethics Commission
Italy: Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Portugal: Ethics Committee for Clinical Research
Switzerland: Ethikkommission
United Kingdom: Research Ethics Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on September 16, 2014