A Prospective, Multicenter, Single-arm, Objective Performance Clinical Investigation For Evaluation of the Safety and Effectiveness of MicroPort™ CardioFlow VitaFlow ™ II Transcatheter Aortic Valve System in the Treatment of Severe Aortic Valve Stenosis

Shanghai MicroPort CardioFlow Medtech Co., Ltd.4 sites in 1 country145 target enrollmentJanuary 31, 2018

ConditionsAortic Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aortic Stenosis
Sponsor: Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Enrollment: 145
Locations: 4
Primary Endpoint: Rate of all-cause mortality at 12 months post implantation
Status: Recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a pre-market clinical investigation aiming to evaluate the safety and effectiveness of Microport™ CardioFlow VitaFlow™ II Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.

Detailed Description

This a prospective, multi-center, single-arm, objective performance clinical investigation, aiming to evaluate the safety and effectiveness of Microport™ CardioFlow VitaFlow™ II Transcatheter Aortic Valve System for the treatment of severe aortic stenosis. A total of 145 subjects will be enrolled in 18 clinical centers within China. Clinical or telephone follow-up is scheduled at 30 days, 6 months, 12 months, and 2-5 years after valve implantation.

Registry

clinicaltrials.gov

Start Date

January 31, 2018

End Date

January 31, 2027

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai MicroPort CardioFlow Medtech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age≥70 years;
•Symptomatic , severe, aortic valve stenosis : peak velocity ≥4.0m/s, or mean transvalvular gradient ≥40mmHg(1 mmHg=0.133kPa), or effective orifice area\<0.8cm² (or EOA index\<0.5cm²/m²);
•NYHA≥II class;
•Estimated life-expectancy\>12 months after implantation of the prosthetic valve;
•Anatomically suitable for the transcatheter aortic valve implantation procedure;
•The patients considered to high-risk or not suitable for surgical aortic valve replacement (SAVR), as assessed by two or above heart surgeons; 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

•Acute myocardial infarction (MI) in last 30 days before the treatment;
•Aortic root anatomy not suitable for the implantation of the transcatheter aortic valve；
•Complicated lesion of the aortic valve (aortic stenosis with severe regurgitation); moderate-severe mitral valve stenosis; severe mitral valve regurgitation; severe tricuspid valve regurgitation;
•Previous implantation of heart valve at any position；
•Hemodynamic instability requiring mechanical hemodynamic support devices;
•Need for emergency surgery for any reason;
•Hypertrophic cardiomyopathy with obstruction;
•Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) \< 20%;Severe right ventricular dysfunction;
•Active peptic ulcer or upper gastro-intestinal bleeding within the past 3 months;
•Known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens, to nitinol, contrast media or other relevant elements.

Outcomes

Primary Outcomes

Rate of all-cause mortality at 12 months post implantation

Time Frame: 12 months post implantation

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

Secondary Outcomes

Rate of major adverse cardiac and cerebrovascular events(MACCE)(at 30 days, 6 months, 1 year and annually up to 5 years post implantation)
Valve function- degree of prosthetic valve regurgitation(at 30 days, 6 months, and 1 year post implantation)
Rate of device success(at immediate post implantation)
Valve function-mean prosthetic valve gradient(at 30 days, 6 months, and 1 year post implantation)
Rate of other TAVI-related complications(at 30 days, 6 months, 1 year and annually up to 5 years post implantation)
Rate of procedure success(at immediate post implantation)
Valve function- effective orifice area(at 30 days, 6 months, and 1 year post implantation)
Rate of safety events according to VARC2(at 30 days, 6 months, 1 year and annually up to 5 years post implantation)
Rate of balloon pre-dilation success(at immediate post implantation)
Rate of balloon post-dilation success(at immediate post implantation)