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

Not Applicable

Completed

• Conditions: Aortic Valve Stenosis
• Interventions: Device: SAPIEN XT NovaFlex delivery system

• Registration Number: NCT01419015
• Lead Sponsor: Edwards Lifesciences

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-08-16
• Study First Submitted QC: 2011-08-16
• Study First Posted: 2011-08-17
• Primary Completion: 2013-01
• Study Completion: 2017-12
• Status Verified: 2020-07
• Results First Submitted: 2020-07-21
• Results First Submitted QC: 2020-07-21
• Last Update Submitted: 2020-07-21
• Results First Posted: 2020-08-06
• Last Update Posted: 2020-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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 %

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TAVI-TF Approach	SAPIEN XT NovaFlex delivery system	Transcatheter aortic valve implantation and transfemoral approach. SAPIEN XT NovaFlex delivery system will be used.

Primary Outcome Measures

Name	Time	Method
NYHA Improvement and AVA >= 0.65 cm2	1 year	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.

Trial Locations

Locations (4)

Sakakibara Heart Institute; 🇯🇵 Fuchu, Toyko, Japan

Osaka University Hospital; 🇯🇵 Suita, Osaka, Japan

Kokura Memorial Hospital; 🇯🇵 Kitakyushu, Fukuoka, Japan

Kurashiki Central Hospital; 🇯🇵 Kurashiki, Okayama, Japan