Stenoses, Aortic Valve Clinical Trial
Official title:
REPRISE China: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus Edge™ Valve System - Clinical Evaluation in China
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.
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. ;