NCT02854319

REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System

REPRISE EDGE: REpositionable Percutaneous Replacement of NatIve StEnotic Aortic Valve Through Implantation of LOTUS EDGE Valve System - Evaluation of Performance and Safety

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

The objective of the REPRISE EDGE study is to confirm the acute performance and safety of the LOTUS Edge™ Valve System when used with the Lotus™ or iSleeve™ Introducer Set for transcatheter aortic valve implantation (TAVI) 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 or Lotus Introducer Set are consistent with the results of the commercially approved 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 Valve Stenosis

Interventions

Type	Name	Description
DEVICE	LOTUS Edge Valve System	Transcatheter Aortic Valve Implantation (TAVI) with the LOTUS Edge™ Valve System when used with the Lotus™ or iSleeve™ Introducer Set

Timeline

• Start date: 2016-09-07
• Primary completion: 2016-10-25
• Completion: 2018-03-13
• First posted: 2016-08-03
• Last updated: 2018-05-31

Locations

3 sites across 3 countries: Denmark, France, Sweden