VitaFlow™ II Transcatheter Aortic Valve System Pre-market Trial

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

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.

Study Overview

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

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.

• Study Type: Interventional
• Enrollment (Anticipated): 145
• Phase: Not Applicable

Contacts and Locations

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

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Fuwai Hospital
      • Contact: Yongjian Wu, Prof; Phone Number: 13701387189
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Zhongshan Hospital
      • Contact: Junbo Ge, Prof; Phone Number: 13901977506
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • West China Hospital of Sichuan University
      • Contact: Mao Chen, Prof; Phone Number: 18980602046
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • The Second Affiliated Hospital Zhejiang University School of Medicine
      • Contact: Jian-An Wang, Prof; Phone Number: 13805786328

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Age≥70 years;
2. 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);
3. NYHA≥II class;
4. Estimated life-expectancy>12 months after implantation of the prosthetic valve;
5. Anatomically suitable for the transcatheter aortic valve implantation procedure;
6. 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:

1. Acute myocardial infarction (MI) in last 30 days before the treatment;
2. Aortic root anatomy not suitable for the implantation of the transcatheter aortic valve；
3. Complicated lesion of the aortic valve (aortic stenosis with severe regurgitation); moderate-severe mitral valve stenosis; severe mitral valve regurgitation; severe tricuspid valve regurgitation;
4. Previous implantation of heart valve at any position；
5. Hemodynamic instability requiring mechanical hemodynamic support devices;
6. Need for emergency surgery for any reason;
7. Hypertrophic cardiomyopathy with obstruction;
8. Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) < 20%;Severe right ventricular dysfunction;
9. Active peptic ulcer or upper gastro-intestinal bleeding within the past 3 months;
10. Known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens, to nitinol, contrast media or other relevant elements.
11. Congenital aortic valve stenosis or unicuspid aortic valve;
12. Vascular diseases or anatomical condition preventing the device access;
13. Active endocarditis or other active infections at the time of treatment;
14. Participating in another trial and the primary endpoint is not achieved.
15. Inability to comply with the clinical investigation follow-up or other requirements.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single arm clinical investigation; Subjects in experimental group will be implanted with the VitaFlow™ II Transcatheter Aortic Valve System	Device: VitaFlow™ II Transcatheter Aortic Valve System; VitaFlow™ II Transcatheter Aortic Valve System contains a valve stent-VitaFlow™ Aortic Valve, a delivery system-VitaFlow™ Delivery System, loading tools, and a guide-wire

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 prosthetic valve gradient	Mean prosthetic valve gradient measured by transthoracic echocardiography (TTE)(in mmHg)	at 30 days, 6 months, and 1 year post implantation
Valve function- effective orifice area	Effective orifice area measured by transthoracic echocardiography (TTE)(in cm^2)	at 30 days, 6 months, and 1 year 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 30 days, 6 months, and 1 year 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, conduction disturbance and arrhythmias, and new permanent pacemaker implantation	at 30 days, 6 months, 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, and TAV-in-TAV	at 30 days, 6 months, 1 year and annually up to 5 years post implantation
Rate of major adverse cardiac and cerebrovascular events(MACCE)	Rate of MACCE including all-cause mortality, stroke, myocardial infarction, re-intervention, arrhythmias, and conduction disturbances	at 30 days, 6 months, 1 year and annually up to 5 years post implantation
Rate of device success	Rate of device success, assessed by death, the access, delivery, deployment and implantation of the device, prosthetic valve position and valve function	at immediate post implantation
Rate of balloon pre-dilation success	Rate of balloon pre-dilation success, assessed by the access, delivery, pre-dilation and retrieval of the balloon catheter	at immediate post implantation
Rate of balloon post-dilation success	Rate of balloon post-dilation success, assessed by the access, delivery, post-dilation and retrieval of the balloon catheter	at immediate post implantation
Rate of procedure success	Rate of procedure success, assessed by the device success and the 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): January 31, 2018
• Primary Completion (Anticipated): January 31, 2022
• Study Completion (Anticipated): January 31, 2027

Study Registration Dates

• First Submitted: May 27, 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: SUPERIOR-2017

Drug and device information, study documents

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