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

Primary Purpose

Aortic Valve Stenosis

Status

Completed

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

Transcatheter aortic valve implantation

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring SAPIEN XT Valve, Cardiovascular Disease, Valvular Heart Disease, Aortic Stenosis, Heart Valve Therapy, Transapical, Transcatheter, Transfemoral

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 %

Sites / Locations

Kurashiki Central Hospital
Osaka University Hospital
Sakakibara Heart Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TAVI - TF and TA approach

Arm Description

Transcatheter aortic valve implantation and transfemoral/ transapical approach

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Death

Death Adverse Event Rate

Full Information

NCT ID

NCT01113983

First Posted

April 29, 2010

Last Updated

April 22, 2020

Sponsor

Edwards Lifesciences

1. Study Identification

Unique Protocol Identification Number

NCT01113983

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

April 1, 2010 (Actual)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Edwards Lifesciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Valve Stenosis

Keywords

SAPIEN XT Valve, Cardiovascular Disease, Valvular Heart Disease, Aortic Stenosis, Heart Valve Therapy, Transapical, Transcatheter, Transfemoral

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TAVI - TF and TA approach

Arm Type

Experimental

Arm Description

Transcatheter aortic valve implantation and transfemoral/ transapical approach

Intervention Type

Device

Intervention Name(s)

Transcatheter aortic valve implantation

Other Intervention Name(s)

SAPIEN XT, NovaFlex delivery system, Ascendra2 delivery system

Intervention Description

Transcatheter aortic valve implantation via transapical and transfemoral approach

Primary Outcome Measure Information:

Title

Improvement of the AVA and NYHA Functional Classification

Description

Time Frame

6 Months

Secondary Outcome Measure Information:

Title

Death

Description

Death Adverse Event Rate

Time Frame

6 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

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 < 18 mm or > 25 mm LVEF < 20 %

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yoshiki Sawa, MD, PhD

Organizational Affiliation

Osaka University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kurashiki Central Hospital

City

Kurashiki

State/Province

Okayama

ZIP/Postal Code

710-8602

Country

Japan

Facility Name

Osaka University Hospital

City

Suita

State/Province

Osaka

ZIP/Postal Code

565-0871

Country

Japan

Facility Name

Sakakibara Heart Institute

City

Chōshi

State/Province

Tokyo

ZIP/Postal Code

183-0003

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28321002

Citation

Sawa Y, Takayama M, Goto T, Takanashi S, Komiya T, Tobaru T, Maeda K, Kuratani T, Sakata Y; PREVAIL JAPAN Investigators. Five-Year Outcomes of the First Pivotal Clinical Trial of Balloon-Expandable Transcatheter Aortic Valve Replacement in Japan (PREVAIL JAPAN). Circ J. 2017 Jul 25;81(8):1102-1107. doi: 10.1253/circj.CJ-17-0111. Epub 2017 Mar 17.

Results Reference

derived

PubMed Identifier

24927855

Citation

Watanabe Y, Hayashida K, Takayama M, Mitsudo K, Nanto S, Takanashi S, Komiya T, Kuratani T, Tobaru T, Goto T, Lefevre T, Sawa Y, Morice MC. First direct comparison of clinical outcomes between European and Asian cohorts in transcatheter aortic valve implantation: the Massy study group vs. the PREVAIL JAPAN trial. J Cardiol. 2015 Feb;65(2):112-6. doi: 10.1016/j.jjcc.2014.05.001. Epub 2014 Jun 11.

Results Reference

derived

PubMed Identifier

24595532

Citation

Sawa Y, Takayama M, Mitsudo K, Nanto S, Takanashi S, Komiya T, Kuratani T, Tobaru T, Goto T. Clinical efficacy of transcatheter aortic valve replacement for severe aortic stenosis in high-risk patients: the PREVAIL JAPAN trial. Surg Today. 2015 Jan;45(1):34-43. doi: 10.1007/s00595-014-0855-y. Epub 2014 Mar 5.

Results Reference

derived

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

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