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

Aortic Valve Stenosis Clinical Trial

Official title:

A Clinical Trial of a Transcatheter Bioprosthetic Valve for Patients With Aortic Stenosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01113983
• Other study ID #: EW-P-001
• Status: Completed
• Phase: N/A
• Start date: April 1, 2010
• Est. completion date: May 2016

Study information

• Verified date: April 2020
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 2016
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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 %

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Device:
• Transcatheter aortic valve implantation
Transcatheter aortic valve implantation via transapical and transfemoral approach

Locations

Country	Name	City	State
Japan	Sakakibara Heart Institute	Choshi	Tokyo
Japan	Kurashiki Central Hospital	Kurashiki	Okayama
Japan	Osaka University Hospital	Suita	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 Months
Secondary	Death	Death Adverse Event Rate	6 months