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Clinical Evaluation of Percutaneous Implantation of the Medtronic CoreValve Aortic Valve Prosthesis (18Fr-Study)

2014-07-23 21:11:03 | BioPortfolio

Summary

The investigation concerns a prospective, multicenter, single arm safety and performance study evaluating the Medtronic CoreValve system. Approximately 120 patients presenting with symptomatic aortic native valve stenosis necessitating valve replacement which are considered poor surgical candidates, with a high surgical risk, as attested to by both the surgeon and the cardiologist are recruited in the study.

Safety and performance will be evaluated at discharge and at 30 days post-procedure. Valve performance and placement will be followed up at 3 and 6 months post-procedure. Further long-term patient follow-up visits will be performed at 12, 24, 36 and 48 months post-procedure.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Aortic Valve Stenosis

Intervention

Medtronic CoreValve System

Location

University of Alberta Hospital
Edmonton
Canada

Status

Active, not recruiting

Source

Medtronic Bakken Research Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:03-0400

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Medical and Biotech [MESH] Definitions

A pathological constriction that can occur above (supravalvular stenosis), below (subvalvular stenosis), or at the AORTIC VALVE. It is characterized by restricted outflow from the LEFT VENTRICLE into the AORTA.

Surgical treatment for severe AORTIC VALVE STENOSIS. Transcatheter aortic valve replacement (TAVR) is used as an alternative option in patients who are deemed at high risk or inoperable for traditional open-heart surgery.

A type of constriction that is caused by the presence of a fibrous ring (discrete type) below the AORTIC VALVE, anywhere between the aortic valve and the MITRAL VALVE. It is characterized by restricted outflow from the LEFT VENTRICLE into the AORTA.

A pathological constriction occurring in the region above the AORTIC VALVE. It is characterized by restricted outflow from the LEFT VENTRICLE into the AORTA.

A pathological constriction occurring in the region below the AORTIC VALVE. It is characterized by restricted outflow from the LEFT VENTRICLE into the AORTA.

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