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

Not Applicable

Completed

• Conditions: Aortic Valve Stenosis
• Interventions: Device: Transcatheter aortic valve implantation

• Registration Number: NCT01113983
• Lead Sponsor: Edwards Lifesciences

Brief 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.

Detailed 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 Timeline

• Study Start: 2010-04-01
• Study First Submitted: 2010-04-29
• Study First Submitted QC: 2010-04-29
• Study First Posted: 2010-04-30
• Primary Completion: 2011-10
• Study Completion: 2016-05
• Results First Submitted: 2019-02-06
• Status Verified: 2020-04
• Results First Submitted QC: 2020-04-22
• Last Update Submitted: 2020-04-22
• Results First Posted: 2020-05-01
• Last Update Posted: 2020-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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 %

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TAVI - TF and TA approach	Transcatheter aortic valve implantation	Transcatheter aortic valve implantation and transfemoral/ transapical approach

Primary Outcome Measures

Name	Time	Method
Improvement of the AVA and NYHA Functional Classification	6 Months	Improvement of the aortic valve area (AVA) and New York Heart Association (NYHA) functional classification from baseline to 6 months after the procedure. NYHA functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I-IV, with the lowest (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort. The AVA at 6 months \> 1.0 cm2 indicates improvement. This outcome measure shows the percentage of patients that had an improvement in both NYHA Class and AVA.

Secondary Outcome Measures

Name	Time	Method
Death	6 months	Death Adverse Event Rate

Trial Locations

Locations (3)

Osaka University Hospital; 🇯🇵 Suita, Osaka, Japan

Kurashiki Central Hospital; 🇯🇵 Kurashiki, Okayama, Japan

Sakakibara Heart Institute; 🇯🇵 Chōshi, Tokyo, Japan