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

NCT ID: NCT01419015

Last Updated: 2020-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2017-12-31

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

Conditions

Aortic Valve Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TAVI-TF Approach

Transcatheter aortic valve implantation and transfemoral approach. SAPIEN XT NovaFlex delivery system will be used.

Group Type: EXPERIMENTAL

SAPIEN XT NovaFlex delivery system

Intervention Type: DEVICE

Transcatheter aortic valve implantation via transfemoral approach.

Interventions

SAPIEN XT NovaFlex delivery system

Transcatheter aortic valve implantation via transfemoral approach.

Intervention Type: DEVICE

Other Intervention Names

SAPIEN XT; NovaFlex delivery system

Eligibility Criteria

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 %

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edwards Lifesciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Morimasa Takayama, MD

Role: PRINCIPAL_INVESTIGATOR

Sakakibara Heart Institute

Locations

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

Countries

Japan

Other Identifiers

EW-P-002

Identifier Type: -

Identifier Source: org_study_id