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Clinical Evaluation of MDT-2111 in Subjects With Small Aortic Annuli and Symptomatic Severe Aortic Stenosis

Aortic Valve Stenosis Clinical Trial

Official title:
Medtronic MDT-2111 CoreValve Japan 23mm Study

Clinical Trial Summary

The primary objective of the present trial is to demonstrate the safety and effectiveness of the MDT-2111 in the treatment of symptomatic severe aortic stenosis in subjects with small aortic annuli and deemed difficult for surgical operation.

Clinical Trial Description

The purpose of this trial is to evaluate the effectiveness and safety of the MDT-2111 TAV system in subjects with small annuli and symptomatic severe AS deemed difficult for surgical intervention. The primary endpoint is a composite of functional effectiveness as measured by improvement of at least 1 New York Heart Association (NYHA) class from baseline to 6 months and anatomical effectiveness as measured by Effective Orifice Area (EOA) ≥1.0 cm² at 6 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01634269
Study type Interventional
Source Medtronic Cardiovascular
Contact
Status Completed
Phase N/A
Start date July 2012
Completion date September 2019
View Details
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