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

Edwards Lifesciences64 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter aortic valve implantationDEVICE

Transcatheter aortic valve implantation via transapical and transfemoral approach

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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 %

Locations (3)

Kurashiki Central Hospital

Kurashiki, Okayama-ken, Japan

Osaka University Hospital

Suita, Osaka, Japan

Sakakibara Heart Institute

Chōshi, Tokyo, Japan

Outcomes

Primary Outcomes

Improvement of the AVA and NYHA Functional Classification

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.

Time frame: 6 Months

Secondary Outcomes

Death

Death Adverse Event Rate

Time frame: 6 months

Data from ClinicalTrials.gov

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