Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement (REPRISE Japan)

Not Applicable

Completed

• Conditions: Aortic Stenosis
• Interventions: Device: Lotus Valve System

• Registration Number: NCT02491255
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

The objective of this study is to confirm the safety and effectiveness of the Lotus™ Valve System in the Japanese medical environment for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native aortic stenosis who are considered at high or extreme risk for surgical valve replacement.

Detailed Description

A prospective, multicenter trial designed to confirm that the safety and effectiveness of the Lotus Valve System in the Japanese medical environment are consistent with the REPRISE III results for TAVR in symptomatic subjects who have calcific, severe native aortic stenosis and who are at extreme or high risk for surgical valve replacement.

Study Timeline

• Study First Submitted: 2015-06-18
• Study Start: 2015-06-22
• Study First Submitted QC: 2015-07-02
• Study First Posted: 2015-07-08
• Primary Completion: 2017-01-30
• Status Verified: 2021-09
• Study Completion: 2021-09-13
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lotus Valve System	Lotus Valve System	Transcatheter aortic valve replacement (TAVR) with Lotus Valve System

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint: Composite of all-cause mortality, stroke, life-threatening and major bleeding events, stage 2 or 3 acute kidney injury, or major vascular complications	30 days following procedure
Primary Effectiveness Endpoint: Composite of all-cause mortality, disabling stroke(adjudicated by an independent CEC), or moderate or greater paravalvular aortic regurgitation(based on independent core laboratory assessment)	6 month following procedure

Secondary Outcome Measures

Name	Time	Method
Moderate or greater paravalvular aortic regurgitation (based on core lab assessment)	6 month following procedure

Trial Locations

Locations (5)

Osaka University Hospital; 🇯🇵 Suita, Osaka, Japan

Shonankamakura General Hospital; 🇯🇵 Kamakura, Kanagawa, Japan

Kurashiki Central Hospital; 🇯🇵 Kurashiki, Okayama, Japan

Sakakibara Heart Institute; 🇯🇵 Fuchu, Tokyo, Japan

Keio University Hospital; 🇯🇵 Shinjuku, Tokyo, Japan