VitaFlow™ Transcatheter Aortic Valve System Post-market Study-The LAUNCH Study
- Conditions
- Aortic Valve Stenosis
- Interventions
- Device: VitaFlow™ Transcatheter Aortic Valve System
- Registration Number
- NCT04414865
- Lead Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
- Brief Summary
The study objective is to evaluate safety and effectiveness/performance of the Microport™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System for the treatment of severe aortic stenosis in the real world settings.
- Detailed Description
This is a prospective, single-arm, multi-center, observational, post-market registry study. The purpose is to evaluate the safety, performance, and effectiveness of the VitaFlow™ Transcatheter Aortic Valve System in the real world settings.Patients will be seen at pre and post procedure, discharge, 30 days, 1 year and annually up to 5 years.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Age≥70 years;
- Symptomatic , calcified, severe, degenerative, native aortic valve stenosis : peak velocity ≥4.0m/s, or mean transvalvular gradient ≥40mmHg(1 mmHg=0.133kPa), or aortic valve area<0.8cm² (or EOA index<0.5cm²/m²);
- The patients considered to be not suitable for surgical aortic valve replacement (SAVR);
- The patient has been informed of the nature of the study, is willing to enroll in the study by signing a patient informed consent and agreeing to the scheduled follow up requirement.
- Aortic root anatomy not suitable for the implantation of the transcatheter aortic valve；
- Vascular diseases or anatomical condition preventing the device access；
- Previous implantation of mechanical or bioprosthesis valve in the aortic position；
- Known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens, to nitinol, contrast media or other relevant elements；
- Ongoing sepsis, including active endocarditis；
- Estimated Life expectancy< 12 months；
- Participating in another trial and the primary endpoint is not achieved.
- Inability to comply with the clinical investigation follow-up or other requirements.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- 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 all-cause mortality at 12 months post implantation 12 months post implantation Rate of all-cause mortality including cardiovascular and non-cardiovascular death
- Secondary Outcome Measures
Name Time Method Rate of safety events according to VARC2 at immediate, 30 days, 1 year and annually up to 5 years post implantation Rate of safety events according to VARC2 including all-cause mortality, myocardial infarction, stroke, bleeding, acute kidney injury, vascular complications, new permanent pacemaker implantation
Rate of balloon pre-dilatation success at immediate post implantation Rate of balloon pre-dilatation success, assessed by the access, delivery, pre-dilatation and retrieval of the balloon catheter
Rate of balloon post-dilatation success at immediate post implantation Rate of balloon pre-dilatation success, assessed by the access, delivery, post-dilatation and retrieval of the balloon catheter
Rate of device success at immediate post implantation Rate of device success, assessed by the access, delivery, deployment and implantation of the device and the prosthetic valve function
Rate of procedure success at immediate post implantation Rate of procedure success, assessed by the device success and peri-procedural complications
Rate of other TAVI-related complications at immediate, 30 days, 1 year and annually up to 5 years post implantation Rate of other TAVI-related complications including conversion to open surgery, unplanned use of cardiopulmonary bypass, coronary obstruction, ventricular septal perforation, mitral valve apparatus damage or dysfunction, cardiac tamponade, endocarditis, valve thrombosis, valve mal-positioning, TAV-in-TAV, valve related dysfunction requiring repeat procedure (TAVI,SAVR,BAV)
Valve function-mean transvalvular gradient at discharge, 30 days, 1 year and annually up to 5 years post implantation Mean transvalvular gradient measured by transthoracic echocardiography (TTE)(in mmHg)
Valve function-effective orifice area at discharge, 30 days, 1 year and annually up to 5 years post implantation Effective orifice area measured by transthoracic echocardiography (TTE)(in cm\^2)
Valve function-degree of prosthetic valve regurgitation at discharge, 30 days, 1 year and annually up to 5 years post implantation Degree of prosthetic valve regurgitation, including paravalvular leak and intravalvular regurgitation measured by transthoracic echocardiography (TTE)
Trial Locations
- Locations (2)
Zhongshan Hospital
🇨🇳Shanghai, Shanghai, China
Ruijing Hospital，Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China