NCT03043404

Performance and Safety of the Lotus™ Valve With a FLEXible Delivery System

REPRISE II FLEX: Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of LotuS™ ValvE With a FLEXible Delivery System - Confirmation of Performance and Safety

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

To confirm the acute performance and safety of the Lotus™ Valve Flex System for transcatheter aortic valve replacement (TAVR) in symptomatic patients with severe calcific aortic stenosis who are considered high risk for surgical valve replacement.

Detailed description

This clinical study is a prospective, single-arm study designed to confirm that the acute performance and safety of the Lotus Valve Flex System for TAVR are consistent with the results of the Lotus Valve System in the REPRISE II study, when delivered and deployed in symptomatic subjects who have severe calcific aortic valve stenosis and who are at high risk for surgical aortic valve replacement (SAVR).

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	Transcatheter aortic valve replacement	TAVR with Lotus Valve Flex System

Timeline

• Start date: 2013-12-03
• Primary completion: 2013-12-10
• Completion: 2018-12-10
• First posted: 2017-02-06
• Last updated: 2019-07-05

Locations

2 sites across 1 country: Australia