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

Aortic Valve Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04414865
• Other study ID #: LAUNCH-2020
• Status: Recruiting
• Start date: April 26, 2020
• Est. completion date: December 30, 2027

Study information

• Verified date: May 2020
• Source: Shanghai MicroPort CardioFlow Medtech Co., Ltd.
• Contact: Zhujun Cai, PhD
• Phone: (86)(21)38954600
• Email: zjcai[@]micoport.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2027
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Device:
• VitaFlow™ Transcatheter Aortic Valve System
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

Locations

Country	Name	City	State
China	Ruijing Hospital,Jiaotong University School of Medicine	Shanghai	Shanghai
China	Zhongshan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai MicroPort CardioFlow Medtech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of all-cause mortality at 12 months post implantation	Rate of all-cause mortality including cardiovascular and non-cardiovascular death	12 months post implantation
Secondary	Valve function-mean transvalvular gradient	Mean transvalvular gradient measured by transthoracic echocardiography (TTE)(in mmHg)	at discharge, 30 days, 1 year and annually up to 5 years post implantation
Secondary	Valve function-effective orifice area	Effective orifice area measured by transthoracic echocardiography (TTE)(in cm^2)	at discharge, 30 days, 1 year and annually up to 5 years post implantation
Secondary	Valve function-degree of prosthetic valve regurgitation	Degree of prosthetic valve regurgitation, including paravalvular leak and intravalvular regurgitation measured by transthoracic echocardiography (TTE)	at discharge, 30 days, 1 year and annually up to 5 years post implantation
Secondary	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	at immediate, 30 days, 1 year and annually up to 5 years post implantation
Secondary	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)	at immediate, 30 days, 1 year and annually up to 5 years post implantation
Secondary	Rate of device success	Rate of device success, assessed by the access, delivery, deployment and implantation of the device and the prosthetic valve function	at immediate post implantation
Secondary	Rate of balloon pre-dilatation success	Rate of balloon pre-dilatation success, assessed by the access, delivery, pre-dilatation and retrieval of the balloon catheter	at immediate post implantation
Secondary	Rate of balloon post-dilatation success	Rate of balloon pre-dilatation success, assessed by the access, delivery, post-dilatation and retrieval of the balloon catheter	at immediate post implantation
Secondary	Rate of procedure success	Rate of procedure success, assessed by the device success and peri-procedural complications	at immediate post implantation