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Cardioband Adjustable Annuloplasty System for Minimally Invasive Mitral Valve Repair

Mitral Valve Insufficiency Clinical Trial

Official title:
Cardioband Adjustable Annuloplasty System for Minimally Invasive Mitral Valve Repair

Clinical Trial Summary

Cardioband is an adjustable annuloplasty band designed for mitral valve repair by a transfemoral delivery system. The aim of this study is to evaluate the performance and safety of the Cardioband for repair of mitral regurgitation.

Clinical Trial Description

The current state of the art management of severe mitral regurgitation is surgical mitral valve repair, either with open chest surgery or mini-thoracotomy. However, standard surgical approaches requiring cardiopulmonary bypass are reserved to fit patients with low or moderate surgical risk, and thus several patients are refused surgery because of unfavorable risk-benefit balance. Cardioband is an adjustable annuloplasty band designed for mitral valve repair by a transfemoral delivery system. Cardioband is intended to remodel the annulus by deployment and fixation along (and direct) the posterior annulus of the mitral valve, in order to correct mitral regurgitation. Adjustment can be performed on a beating heart, to optimize correction of mitral regurgitation. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01533883
Study type Observational
Source Valtech Cardio Ltd
Contact
Status Active, not recruiting
Phase N/A
Start date September 2011
Completion date June 2018
View Details
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