NCT02491255

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

REPRISE Japan: Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Clinical Evaluation in Japan

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	Lotus Valve System	Device: Lotus Valve System

Timeline

• Start date: 2015-06-22
• Primary completion: 2017-01-30
• Completion: 2021-09-13
• First posted: 2015-07-08
• Last updated: 2021-09-28

Locations

5 sites across 1 country: Japan