VitaFlow™ II Transcatheter Aortic Valve System Pre-market Trial

Not Applicable

Recruiting

• Conditions: Aortic Stenosis
• Interventions: Device: VitaFlow™ II Transcatheter Aortic Valve System

• Registration Number: NCT04414878
• Lead Sponsor: Shanghai MicroPort CardioFlow Medtech Co., Ltd.

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.

Study Timeline

• Study Start: 2018-01-31
• Status Verified: 2020-05
• Study First Submitted: 2020-05-27
• Study First Submitted QC: 2020-05-31
• Last Update Submitted: 2020-05-31
• Study First Posted: 2020-06-04
• Last Update Posted: 2020-06-04
• Primary Completion: 2022-01-31
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 145

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm clinical investigation	VitaFlow™ II Transcatheter Aortic Valve System	Subjects in experimental group will be implanted with the VitaFlow™ II Transcatheter Aortic Valve System

Primary Outcome Measures

Name	Time	Method
Rate of all-cause mortality at 12 months post implantation	12 months post implantation	Rate of all-cause mortality including cardiovascular and non-cardiovascular death

Secondary Outcome Measures

Name	Time	Method
Rate of major adverse cardiac and cerebrovascular events(MACCE)	at 30 days, 6 months, 1 year and annually up to 5 years post implantation	Rate of MACCE including all-cause mortality, stroke, myocardial infarction, re-intervention, arrhythmias, and conduction disturbances
Valve function- degree of prosthetic valve regurgitation	at 30 days, 6 months, and 1 year post implantation	Degree of prosthetic valve regurgitation including paravalvular leak and intravalvular regurgitation measured by transthoracic echocardiography (TTE)
Rate of device success	at immediate post implantation	Rate of device success, assessed by death, the access, delivery, deployment and implantation of the device, prosthetic valve position and valve function
Valve function-mean prosthetic valve gradient	at 30 days, 6 months, and 1 year post implantation	Mean prosthetic valve gradient measured by transthoracic echocardiography (TTE)(in mmHg)
Rate of other TAVI-related complications	at 30 days, 6 months, 1 year and annually up to 5 years post implantation	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
Rate of procedure success	at immediate post implantation	Rate of procedure success, assessed by the device success and the peri-procedural complications
Valve function- effective orifice area	at 30 days, 6 months, and 1 year post implantation	Effective orifice area measured by transthoracic echocardiography (TTE)(in cm\^2)
Rate of safety events according to VARC2	at 30 days, 6 months, 1 year and annually up to 5 years post implantation	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
Rate of balloon pre-dilation success	at immediate post implantation	Rate of balloon pre-dilation success, assessed by the access, delivery, pre-dilation and retrieval of the balloon catheter
Rate of balloon post-dilation success	at immediate post implantation	Rate of balloon post-dilation success, assessed by the access, delivery, post-dilation and retrieval of the balloon catheter

Trial Locations

Locations (4)

Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China

Fuwai Hospital; 🇨🇳 Beijing, Beijing, China

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China

The Second Affiliated Hospital Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China