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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: VitaFlow™ Transcatheter Aortic Valve System

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Zhujun Cai, PhD; Phone Number: (86)(21)38954600; Email: zjcai@micoport.com
• Study Contact Backup: Name: Jie Bi; Phone Number: (86)(21)38954600; Email: jbi@micoport.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Zhongshan Hospital
      • Contact: Daxin Zhou, Prof; Phone Number: 13801641512; Email: zhou.daxin@zs-hospital.sh.cn
    • Shanghai, Shanghai, China
      • Not yet recruiting
      • Ruijing Hospital，Jiaotong University School of Medicine
      • Contact: Ruiyan Zhang, Prof; Phone Number: 13601911729; Email: zhangruiyan@263.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population includes symptomatic patients (≥70 years old ) with calcified, severe, degenerative, native aortic valve stenosis who are not suitable for the surgical aortic valve replacement as assessed by the heart team

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
single arm, treatment group; Subjects in the treatment group will be implanted with the VitaFlow™ Transcatheter Aortic Valve System	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
Rate of procedure success	Rate of procedure success, assessed by the device success and peri-procedural complications	at immediate post implantation

Collaborators and Investigators

• Sponsor: Shanghai MicroPort CardioFlow Medtech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 26, 2020
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): December 30, 2027

Study Registration Dates

• First Submitted: May 26, 2020
• First Submitted That Met QC Criteria: May 31, 2020
• First Posted (ACTUAL): June 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 4, 2020
• Last Update Submitted That Met QC Criteria: May 31, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: LAUNCH-2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No