VitaFlow™ Transcatheter Aortic Valve System Pre-market Trial

Study Overview
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Brief Summary
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This is a pre-market clinical investigation aiming to evaluate the safety and effectiveness of MicroPort™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.

Detailed Description
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This is a prospective, multi-center, single-arm clinical investigation for evaluation of the safety and effectiveness of the MicroPort™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System in the Treatment of Severe Aortic Stenosis. The investigation has two phases. Phase I（FIM）：The FIM stage is a prospective, multicenter, single-arm observational clinical investigation, aiming to evaluate the feasibility and safety of the MicroPort™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System. A total of 10 patients will be enrolled and 30-day clinical outcomes will be collected. Phase II (Pivotal)：The pivotal stage is a prospective, multi-center, single-arm clinical investigation with the performance goal, aiming to evaluate the safety and effectiveness of MicroPort™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System for the treatment of severe aortic stenosis. A total of 110 patients will be enrolled in 11 clinical centers across China. Clinical or telephone follow-up is scheduled at 30 days, 6 months, 12 months, and 2 to 5 years annually post-procedure.

Official Title
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A Prospective, Multi-center, Single-arm Clinical Investigation for Evaluation of the Safety and Effectiveness of the MicroPort™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System in the Treatment of Severe Aortic Stenosis

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Device: VitaFlow™ Transcatheter Aortic Valve System


Participation Criteria
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Eligibility Criteria
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Inclusion criteria : Enrollment was limited to patients who met all of the following criteria: Age ≥ 70 years old(Phase II)/Age ≥18 years old,male or female who are not pregnant (Phase I); Patients have severe aortic stenosis: Mean gradient> 40mmHg(1mmHg = 0.133kPa), or peak velocity> 4m/s, or an aortic valve area(AVA) <1.0 cm² (or AVA index <0.6 cm²/m²); NYHA classification ≥ II; Life expectancy> 12 months; Anatomically suitable for transcatheter aortic valve implantation; Assessed by a multidisciplinary heart team as a patient unsuitable for surgical aortic valve replacement; Patients who can understand the purpose of the investigation, volunteer to participate in and sign the informed consent form, and are willing to comply with relevant examinations and follow-up visits. Exclusion criteria: Acute myocardial infarction occurred within 30 days before the treatment; Patients with congenital unicuspid aortic valve or aortic root anatomy and lesions that are not suitable for transcatheter valve implantation; Any therapeutic heart surgery within 30 days; Mixed aortic valve disease(aortic stenosis with severe regurgitation); moderate and severe mitral stenosis; severe mitral regurgitation; severe tricuspid regurgitation; Blood dyscrasia, including neutropenia (WBC < 3 × 10^9/L), acute anemia(HB <90 g/L), thrombocytopenia(PLT <50 × 10^9/L), hemorrhagic constitution, and coagulopathy disease; Untreated coronary artery disease requiring revascularization; Hemodynamic instability requiring systolic support or mechanical heart assistance; Need for emergency surgery for any reason; Obstructive hypertrophic cardiomyopathy; Severe left ventricular dysfunction, left ventricular ejection fraction(LVEF) < 20%; severe pulmonary hypertension and right ventricular dysfunction; Echocardiography suggests the presence of intracardiac masses, thrombi, or neoplasms; Active peptic ulcer or history of upper gastrointestinal bleeding within 3 months; Allergy to aspirin, heparin, ticlopidine, clopidogrel, nitinol, or contrast agents; Cerebrovascular events including transient ischemic attack(TIA) occurred within 6 months; Renal insufficiency decompensation(end creatinine clearance < 20ml/min), and / or end-stage renal disease require long-term dialysis treatment; Vascular diseases affecting device access; Active infectious endocarditis or other active infection; Participated in clinical investigations of other drugs or medical devices before the election, and had not completed the primary endpoint; The investigator judged that the patient had poor compliance and could not complete the study as required.

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single arm, treatment group<br>Subjects in the treatment group will be implanted with the VitaFlow™ Transcatheter Aortic Valve System | Device: VitaFlow™ Transcatheter Aortic Valve System<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of device success-Phase I |  | at immediate post-procedure | 
| All-cause mortality at 12 months post implantation-Phase II |  | at 12 months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of major adverse events -Phase I |  | at 30 days post implantation | 
| Hemodynamic performance-Phase II | Hemodynamic performance, including the mean prosthetic valve gradient(in mmHg), the Effective orifice(in cm^2), and the degree of prosthetic valve regurgitation measured by transthoracic echocardiography (TTE) | at immediate post-procedure, discharge, 30 days, 6 months, 1 year and annually up to 5 years post implantation | 
| Heart function(NYHA)-Phase II |  | at immediate post-procedure, discharge, 30 days, 6 months, 1 year and annually up to 5 years post implantation | 
| Rate of safety events according to VARC2-Phase II |  | at immediate, 30 days, 1 year and annually up to 5 years post implantation | 
| Rate of major cardiovascular and cerebrovascular events(MACCE)-Phase II |  | at immediate, 30 days, 1 year and annually up to 5 years post implantation | 
| Rate of balloon pre-dilatation success-Phase II |  | at immediate post implantation | 
| Rate of balloon post-dilatation success-Phase II |  | at immediate post implantation |