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

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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: Transcatheter aortic valve implantation

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Okayama
    • Kurashiki, Okayama, Japan, 710-8602
      • Kurashiki Central Hospital
  • Osaka
    • Suita, Osaka, Japan, 565-0871
      • Osaka University Hospital
  • Tokyo
    • Chōshi, Tokyo, Japan, 183-0003
      • Sakakibara Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 %

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAVI - TF and TA approach; Transcatheter aortic valve implantation and transfemoral/ transapical approach	Device: Transcatheter aortic valve implantation; Transcatheter aortic valve implantation via transapical and transfemoral approach; Other Names: SAPIEN XT; NovaFlex delivery system; Ascendra2 delivery system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Death Adverse Event Rate	6 months

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• Investigators: Principal Investigator: Yoshiki Sawa, MD, PhD, Osaka University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2010
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: April 29, 2010
• First Submitted That Met QC Criteria: April 29, 2010
• First Posted (Estimate): April 30, 2010

Study Record Updates

• Last Update Posted (Actual): May 1, 2020
• Last Update Submitted That Met QC Criteria: April 22, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: SAPIEN XT Valve, Cardiovascular Disease, Valvular Heart Disease, Aortic Stenosis, Heart Valve Therapy, Transapical, Transcatheter, Transfemoral
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: EW-P-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes