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The Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family) Post Marketing Surveillance (PMS) (CoreValve India PMS) — CoreValveIndia  

Symptomatic Aortic Stenosis Clinical Trial

Official title:
The Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family) Post Marketing Surveillance (PMS) (CoreValve India PMS)

Clinical Trial Summary

The Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family) has been demonstrated to be safe and effective for high through extreme risk patients with symptomatic severe native aortic stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure. Per DCGI systematic post marketing surveillance requirement, the purpose of this PMS plan is to provide local post marketing surveillance data regarding the safety of Medtronic CoreValve System Family

Clinical Trial Description

The objective of this PMS will be to monitor and gather data on the safety of The Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family) in the approved intended use.

The main focus of this PMS will be to generate additional information and report on all major adverse events up to 30 days from the day of implant procedure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02759237
Study type Observational
Source Medtronic Cardiovascular
Contact
Status Terminated
Phase N/A
Start date February 2016
Completion date May 2017
View Details
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