A Prospective, Multi-center, Single-arm Clinical Investigation for Evaluation of the Safety and Effectiveness of the MicroPort™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System in the Treatment of Severe Aortic Stenosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Valve Stenosis
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
- Enrollment
- 120
- Locations
- 4
- Primary Endpoint
- Rate of device success-Phase I
- Last Updated
- 5 years ago
Overview
Brief Summary
This is a pre-market clinical investigation aiming to evaluate the safety and effectiveness of MicroPort™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.
Detailed Description
This is a prospective, multi-center, single-arm clinical investigation for evaluation of the safety and effectiveness of the MicroPort™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System in the Treatment of Severe Aortic Stenosis. The investigation has two phases. Phase I（FIM）：The FIM stage is a prospective, multicenter, single-arm observational clinical investigation, aiming to evaluate the feasibility and safety of the MicroPort™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System. A total of 10 patients will be enrolled and 30-day clinical outcomes will be collected. Phase II (Pivotal)：The pivotal stage is a prospective, multi-center, single-arm clinical investigation with the performance goal, aiming to evaluate the safety and effectiveness of MicroPort™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System for the treatment of severe aortic stenosis. A total of 110 patients will be enrolled in 11 clinical centers across China. Clinical or telephone follow-up is scheduled at 30 days, 6 months, 12 months, and 2 to 5 years annually post-procedure.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Rate of device success-Phase I
Time Frame: at immediate post-procedure
All-cause mortality at 12 months post implantation-Phase II
Time Frame: at 12 months post-procedure
Secondary Outcomes
- Heart function(NYHA)-Phase II(at immediate post-procedure, discharge, 30 days, 6 months, 1 year and annually up to 5 years post implantation)
- Rate of major adverse events -Phase I(at 30 days post implantation)
- Hemodynamic performance-Phase II(at immediate post-procedure, discharge, 30 days, 6 months, 1 year and annually up to 5 years post implantation)
- Rate of safety events according to VARC2-Phase II(at immediate, 30 days, 1 year and annually up to 5 years post implantation)
- Rate of major cardiovascular and cerebrovascular events(MACCE)-Phase II(at immediate, 30 days, 1 year and annually up to 5 years post implantation)
- Rate of balloon pre-dilatation success-Phase II(at immediate post implantation)
- Rate of balloon post-dilatation success-Phase II(at immediate post implantation)