Transfemoral Implant of Inovare® Transcatheter Valve

Status Active, not recruiting

Clinical Trial Summary

Clinical trial to evaluate the early safety and efficacy of the transfemoral implant of Inovare® Transcatheter Valve for the treatment of patients with severe degenerative aortic stenosis and high surgical risk.

Clinical Trial Description

The Inovare® transcatheter valve was developed and has been market ed since 2011 for replacement, via transapical or transaortic route, of calcified native aortic valves and degenerated bioprostheses (aortic and mitral) with satisfactory medium-long-term results. The present study aims to evaluate the safety and clinical performance of the new navigation and delivery system of this device using the transfemoral route. The new device has as its main feature the drivable control of the curvature of the delivery system, the which allows better navigability in regions of more complex anatomy, especially with accentuated tortuosities. ;

Study Design

Related Conditions & MeSH terms

Aortic Valve Stenosis

Clinical Trial Details

NCT number	NCT05531578
Study type	Interventional
Source	Braile Biomedica Ind. Com. e Repr. Ltda.
Contact
Status	Active, not recruiting
Phase	N/A
Start date	September 11, 2020
Completion date	December 30, 2028

View Details

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