A Prospective, Multi-center, Post-market Registry Study Evaluating Safety and Effectiveness of the Microport™CardioFlow VitaFlow™Transcatheter Aortic Valve System for the Treatment of Severe Aortic Stenosis

Shanghai MicroPort CardioFlow Medtech Co., Ltd.2 sites in 1 country100 target enrollmentApril 26, 2020

ConditionsAortic Valve Stenosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Aortic Valve Stenosis
Sponsor: Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Enrollment: 100
Locations: 2
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

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.

Registry

clinicaltrials.gov

Start Date

April 26, 2020

End Date

December 30, 2027

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Shanghai MicroPort CardioFlow Medtech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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.

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