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REpositionable Versus BallOOn-expandable Prosthesis for Trans-catheter Aortic Valve Implantation — REBOOT  

Aortic Valve Disease Clinical Trial

Official title:
Randomized Comparison of Repositionable and Balloon-Expandable Prostheses in Patients Undergoing Trans-catheter Aortic Valve Implantation

Clinical Trial Summary

There are different aortic valve prosthesis used for treatment of aortic valve disease through catheter-based procedures. The current study aims to compare two different aortic valve prosthesis regarding their outcomes at 30-day and 2-year follow-up.

Clinical Trial Description

Important improvements in aortic valve prostheses technology has been made aiming comparable performance of these prosthesis to surgical valve ones.

The experience with the early generation of aortic valve prostheses revealed some important differences regarding the incidence of paravalvular leakage, need for pacemaker or valve thrombosis among them. Currently the new generations of valve prostheses such as Sapien 3 balloon-expandable valve and Lotus, repositionable valve are the most frequently used devices. There are registry data about the clinical performance of these valve types but a randomized comparison is missing. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02668484
Study type Interventional
Source Klinikum der Universitaet Muenchen
Contact
Status Completed
Phase N/A
Start date January 2016
Completion date May 31, 2019
View Details
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