NCT01627691

REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System

REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Evaluation of Safety and Performance

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and performance of the Lotus™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with severe calcific aortic stenosis who are considered high risk for surgical valve replacement.

Detailed description

The REPRISE II clinical study is a prospective, single-arm, multicenter study designed to evaluate the safety and performance of the Lotus Valve System for TAVR in symptomatic subjects who have severe calcific aortic valve stenosis and who are at high risk for surgical aortic valve replacement (SAVR).

Conditions

• Transcatheter Aortic Valve Replacement

Interventions

Type	Name	Description
DEVICE	Lotus Valve System	* bioprosthetic bovine pericardial aortic valve * delivery system

Timeline

• Start date: 2012-10-08
• Primary completion: 2014-05-30
• Completion: 2019-05-13
• First posted: 2012-06-26
• Last updated: 2020-05-12
• Results posted: 2019-09-10

Locations

20 sites across 9 countries: Australia, France, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom