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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-01

Study Completion Date

2016-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Aortic Valve Stenosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TAVI - TF and TA approach

Transcatheter aortic valve implantation and transfemoral/ transapical approach

Group Type EXPERIMENTAL

Transcatheter aortic valve implantation

Intervention Type DEVICE

Transcatheter aortic valve implantation via transapical and transfemoral approach

Interventions

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Transcatheter aortic valve implantation

Transcatheter aortic valve implantation via transapical and transfemoral approach

Intervention Type DEVICE

Other Intervention Names

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SAPIEN XT NovaFlex delivery system Ascendra2 delivery system

Eligibility Criteria

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Inclusion Criteria

* Patients who were judged difficult to safely undergo AVR
* Severe senile degenerative aortic valve stenosis
* NYHA Functional Class II or greater
* Signed Informed Consent