NCT02759237

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 3 (actual)
• Sponsor: Medtronic Cardiovascular · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Symptomatic Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	CoreValve System Family	Bioprosthesis: Transcatheter Aortic Valve Implant (TAV - Heart Valve) -Different Models/Sizes of CoreValve/CoreValve Evolut R. Delivery Catheter System: ACCUTRAK \& EnVeo R - Used to facilitate the placement of the bioprosthesis within the annulus. Loading System: Compression Loading System \& EnVeo R Loading System - Used to load the TAV onto the delivery system

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2016-05-03
• Last updated: 2017-06-14

Locations

1 site across 1 country: India