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

Edwards Lifesciences

Status: Completed

Conditions: Aortic Valve Stenosis

Treatments: Device: Transcatheter aortic valve implantation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01113983

EW-P-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• Aortic valve is congenital unicuspid or bicuspid
• Annulus size between < 18 mm or > 25 mm
• LVEF < 20 %

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 1 patient group

TAVI - TF and TA approach

Experimental group

Description:

Transcatheter aortic valve implantation and transfemoral/ transapical approach

Treatment:

Device: Transcatheter aortic valve implantation