VitaFlow™ Transcatheter Aortic Valve System Pre-market Trial
- Conditions
- Aortic Valve Stenosis
- Interventions
- Device: VitaFlow™ Transcatheter Aortic Valve System
- Registration Number
- NCT04655742
- Lead Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description single arm, treatment group VitaFlow™ Transcatheter Aortic Valve System Subjects in the treatment group will be implanted with the VitaFlow™ Transcatheter Aortic Valve System
- Primary Outcome Measures
Name Time Method Rate of device success-Phase I at immediate post-procedure All-cause mortality at 12 months post implantation-Phase II at 12 months post-procedure
- Secondary Outcome Measures
Name Time Method 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 Hemodynamic performance, including the mean prosthetic valve gradient(in mmHg), the Effective orifice(in cm\^2), and the degree of prosthetic valve regurgitation measured by transthoracic echocardiography (TTE)
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
Trial Locations
- Locations (4)
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
Fuwai Hospital
🇨🇳Beijing, Beijing, China
Zhongshan Hospital Fudan University
🇨🇳Shanghai, Shanghai, China
The Second Affiliated Hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China