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

Aortic Valve Stenosis Clinical Trial

— PREVAIL-20J  

Official title:

A Clinical Trial of a 20mm Transcatheter Bioprosthetic Valve for Patients With Aortic Stenosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01419015
• Other study ID #: EW-P-002
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Est. completion date: December 2017

Study information

• Verified date: July 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 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 2017
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years 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 < 16 mm or > 19 mm

• LVEF < 20 %

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Device:
• SAPIEN XT NovaFlex delivery system
Transcatheter aortic valve implantation via transfemoral approach.

Locations

Country	Name	City	State
Japan	Sakakibara Heart Institute	Fuchu	Toyko
Japan	Kokura Memorial Hospital	Kitakyushu	Fukuoka
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	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.	1 year