NCT02329496

REPRISE Next Generation Delivery System

REPRISE NGDS: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of LotuS™ ValvE With the Next Generation Delivery System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (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 with the Next Generation Delivery 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 demonstrate that the acute performance and safety of the LOTUS Edge Valve System when used with the iSleeve Introducer Set or current Lotus Introducer Set are consistent with the results of the Lotus Valve System used 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	Lotus Valve and LOTUS Edge Valve System	Transcatheter aortic valve replacement (TAVR) with the Lotus Valve System with the Next Generation Delivery System and LOTUS Edge Valve System, with either the Lotus Introducer or iSleeve Introducer Sets

Timeline

• Start date: 2014-12-03
• Primary completion: 2016-10-06
• Completion: 2017-10-19
• First posted: 2014-12-31
• Last updated: 2018-05-24

Locations

2 sites across 1 country: Australia