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PREVAIL-J - Transfemoral & Transapical Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Japan)

Aortic Valve Stenosis Clinical Trial

Official title:
A Clinical Trial of a Transcatheter Bioprosthetic Valve for Patients With Aortic Stenosis

Clinical Trial Summary

A single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral delivery system, Ascendra2™ transapical delivery system and crimper accessories. The trial includes a premarket pivotal cohort to evaluate the system performance as well as a post market clinical follow-up phase involving long term follow-up of all patients to evaluate the safety of investigational devices up to 5 years.

Clinical Trial Description

Purpose: To evaluate the safety and efficacy of THV-9300 for patients who have severe symptomatic aortic stenosis attributed to calcification and degeneration of a valve leaflet and for whom undergoing a surgery safely would be difficult.

Follow-up: Subject data collection will include clinical information at baseline and during the index procedure. Subjects will undergo clinical follow-up at discharge, 30 days, 6 months and annually for 5 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01113983
Study type Interventional
Source Edwards Lifesciences
Contact
Status Completed
Phase N/A
Start date April 1, 2010
Completion date May 2016
View Details
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