Overview

This trial is active, not recruiting.

Condition severe aortic stenosis
Treatment medtronic corevalve system
Phase phase 4
Sponsor Medtronic Bakken Research Center
Start date March 2010
End date November 2011
Trial size 1015 participants
Trial identifier NCT01074658, Advance

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
elderly patients with severe aortic valve stenosis requiring treatment
medtronic corevalve system
Transcatheter Aortic Valve Implantation of the Medtronic CoreValve System

Primary Outcomes

Measure
Major Adverse Cardiac & Cerebrovascular Events (MACCE)
time frame: 30 days post procedure

Secondary Outcomes

Measure
Device success
time frame: Procedure
Procedural success
time frame: In-hospital stay

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title CoreValve Advance International Post Market Study: Evaluation of the Medtronic CoreValve System in a "Real-World" Patient Population.
Principal investigator Axel Linke, Prof Dr med
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Medtronic Cardiovascular.