VitaFlow™ Transcatheter Aortic Valve System Post-market Study-The LAUNCH Study

Shanghai MicroPort CardioFlow Medtech Co., Ltd.100 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Aortic Valve Stenosis

Interventions

VitaFlow™ Transcatheter Aortic Valve SystemDEVICE

VitaFlow™ Transcatheter Aortic Valve System contains a valve stent-VitaFlow™ Aortic Valve, a delivery system-VitaFlow™ Delivery System,loading tools, a balloon dilatation catheter, and an introducer set

Eligibility

Sex: ALLMin age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (2)

Ruijing Hospital，Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

NOT_YET_RECRUITING

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Rate of all-cause mortality at 12 months post implantation

Rate of all-cause mortality including cardiovascular and non-cardiovascular death

Time frame: 12 months post implantation

Secondary Outcomes

Valve function-mean transvalvular gradient

Mean transvalvular gradient measured by transthoracic echocardiography (TTE)(in mmHg)

Time frame: at discharge, 30 days, 1 year and annually up to 5 years post implantation

Valve function-effective orifice area

Effective orifice area measured by transthoracic echocardiography (TTE)(in cm\^2)

Time frame: at discharge, 30 days, 1 year and annually up to 5 years post implantation

Valve function-degree of prosthetic valve regurgitation

Degree of prosthetic valve regurgitation, including paravalvular leak and intravalvular regurgitation measured by transthoracic echocardiography (TTE)

Time frame: at discharge, 30 days, 1 year and annually up to 5 years post implantation

Rate of safety events according to VARC2

Rate of safety events according to VARC2 including all-cause mortality, myocardial infarction, stroke, bleeding, acute kidney injury, vascular complications, new permanent pacemaker implantation

Time frame: at immediate, 30 days, 1 year and annually up to 5 years post implantation

Rate of other TAVI-related complications

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)

Central Contacts

Zhujun Cai, PhD

CONTACT

(86)(21)38954600 zjcai@micoport.com

Jie Bi

CONTACT

(86)(21)38954600 jbi@micoport.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.