NCT01383720

REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve SystEm

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-arm feasibility study designed to assess the acute safety and performance of the Lotus Valve System for transcatheter aortic valve replacement in symptomatic patients with calcified aortic valve stenosis and who are at high risk for surgical intervention.

Detailed description

The incidence of aortic stenosis is increasing due to the aging of the world-wide population and the lack of drug therapies to prevent, halt, or effectively slow the stenotic process. Transcatheter aortic valve replacement has become a viable alternative for treatment of severe symptomatic aortic stenosis in selected patients who are unsuitable candidates for surgical valve replacement. The Lotus Valve System is designed to enable precise placement and minimize or eliminate the paravalvular regurgitation and associated adverse events seen with earlier generation devices. The REPRISE I study assesses acute safety and performance.

Conditions

• Aortic Valve Stenosis
• Aortic Valve Calcification
• Aortic Valve Disease

Interventions

Type	Name	Description
DEVICE	Lotus Valve System	The Lotus Valve System includes the Lotus Valve, a bovine tissue tri-leaflet bioprosthetic aortic valve, and the Lotus Delivery Catheter for guidance and placement.

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-05-01
• Completion: 2017-05-09
• First posted: 2011-06-28
• Last updated: 2017-06-20
• Results posted: 2016-05-09

Locations

3 sites across 1 country: Australia