NCT03084510

REPRISE China - Clinical Evaluation in China

REPRISE China: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Edge™ Valve System - Clinical Evaluation in China

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and effectiveness of the Lotus Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic Chinese patients with calcific, severe native aortic stenosis who are considered at high risk for surgical valve replacement.

Detailed description

1. A independent Clinical Events Committee (CEC) will adjudge the safety endpoint. 2. Subject has a documented aortic annulus size of ≥20 mm and ≤27 mm based on the center's assessment of pre-procedure diagnostic imaging (and confirmed by the Case Review Committee \[CRC\]). 3. Monitor will review the source data regularly to compare the EDC to ensure the data entry can be accuracy, completeness, or representativeness. 4. Will recruit maximum 62 subjects in maximum 6 sites 5. Boston Scientific's Standard Operating Procedures to address operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management.

Conditions

• Stenoses, Aortic Valve

Interventions

Type	Name	Description
DEVICE	Lotus Edge™ Valve System	• The Lotus Edge™ Valve System consisting of two main components: * a bioprosthetic bovine pericardial aortic valve, and * a delivery system Device sizes include 23 mm, 25 mm and 27 mm diameter.

Timeline

• Start date: 2020-02-28
• Primary completion: 2020-11-30
• Completion: 2020-11-30
• First posted: 2017-03-21
• Last updated: 2023-11-15

Locations

1 site across 1 country: China