PREVAIL-20J - Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial

N/ACompletedNCT01419015

Edwards Lifesciences17 enrolled

Overview

A single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the 20mm Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral 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 (20mm) 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. Enrollment: 15 patients (No.of patients needed: 12) 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. Clinical sites: 1)Osaka University Hospital, 2)Kurashiki Central Hospital, 3)Sakakibara Heart Institute, 4) Kokura Memorial Hospital

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aortic Valve Stenosis

Interventions

SAPIEN XT NovaFlex delivery systemDEVICE

Transcatheter aortic valve implantation via transfemoral approach.

Eligibility

Sex: ALLMin age: 19 Years

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 \< 16 mm or \> 19 mm * LVEF \< 20 %

Locations (4)

Kokura Memorial Hospital

Kitakyushu, Fukuoka, Japan

Kurashiki Central Hospital

Kurashiki, Okayama-ken, Japan

Osaka University Hospital

Suita, Osaka, Japan

Sakakibara Heart Institute

Fuchū, Toyko, Japan

Outcomes

Primary Outcomes

NYHA Improvement and AVA >= 0.65 cm2

Improvement of the aortic valve area (AVA) and New York Heart Association (NYHA) functional classification from baseline to 1 year 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 1 year \>= 0.65 cm2 indicates improvement. This outcome measure shows the percentage of patients that had an improvement in both NYHA Class and AVA. Note: One patient did not complete a 6-month echo.

Time frame: 1 year

Data from ClinicalTrials.gov

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