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

NCT01113983 | Completed Results DMC FDA Device

• 1 other identifier: EW-P-001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 3

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.

Conditions

Aortic Valve Stenosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Death

  6 months

Study Arms (1)

TAVI - TF and TA approach

EXPERIMENTAL

Transcatheter aortic valve implantation and transfemoral/ transapical approach

Device: Transcatheter aortic valve implantation

Interventions

Transcatheter aortic valve implantation DEVICE

Transcatheter aortic valve implantation via transapical and transfemoral approach

Also known as: SAPIEN XT, NovaFlex delivery system, Ascendra2 delivery system

TAVI - TF and TA approach

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who were judged difficult to safely undergo AVR
• Severe senile degenerative aortic valve stenosis
• NYHA Functional Class II or greater
• Signed Informed Consent

You may not qualify if:

• Aortic valve is congenital unicuspid or bicuspid
• Annulus size between \< 18 mm or \> 25 mm
• LVEF \< 20 %

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (3)

Kurashiki Central Hospital

Kurashiki, Okayama-ken, 710-8602, Japan

Location

Osaka University Hospital

Suita, Osaka, 565-0871, Japan

Location

Sakakibara Heart Institute

Chōshi, Tokyo, 183-0003, Japan

Location

Related Publications (3)

• 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.

  PMID: 28321002 DERIVED

• 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.

  PMID: 24927855 DERIVED

• 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.

  PMID: 24595532 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis; Cardiovascular Diseases; Heart Valve Diseases

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Results Point of Contact

• Title: Shin Sakai, PhD
• Organization: Edwards Lifesciences

shin_sakai@edwards.com

Study Officials

• Yoshiki Sawa, MD, PhD

  Osaka University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2010
• First Posted: April 30, 2010
• Study Start: April 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: May 1, 2016
• Last Updated: May 1, 2020
• Results First Posted: May 1, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (3)