REPRISE Japan: Repositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System - Clinical Evaluation in Japan
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Stenosis
- Sponsor
- Boston Scientific Corporation
- Enrollment
- 70
- Locations
- 5
- Primary Endpoint
- Primary Safety Endpoint: Composite of all-cause mortality, stroke, life-threatening and major bleeding events, stage 2 or 3 acute kidney injury, or major vascular complications
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
The objective of this study is to confirm the safety and effectiveness of the Lotus™ Valve System in the Japanese medical environment for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native aortic stenosis who are considered at high or extreme risk for surgical valve replacement.
Detailed Description
A prospective, multicenter trial designed to confirm that the safety and effectiveness of the Lotus Valve System in the Japanese medical environment are consistent with the REPRISE III results for TAVR in symptomatic subjects who have calcific, severe native aortic stenosis and who are at extreme or high risk for surgical valve replacement.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Primary Safety Endpoint: Composite of all-cause mortality, stroke, life-threatening and major bleeding events, stage 2 or 3 acute kidney injury, or major vascular complications
Time Frame: 30 days following procedure
Primary Effectiveness Endpoint: Composite of all-cause mortality, disabling stroke(adjudicated by an independent CEC), or moderate or greater paravalvular aortic regurgitation(based on independent core laboratory assessment)
Time Frame: 6 month following procedure
Secondary Outcomes
- Moderate or greater paravalvular aortic regurgitation (based on core lab assessment)(6 month following procedure)