VitaFlow™ II Transcatheter Aortic Valve System Pre-market Trial
ConditionAortic Stenosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorShanghai MicroPort CardioFlow Medtech Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age≥70 years;
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);
NYHA≥II class;
Estimated life-expectancy>12 months after implantation of the prosthetic valve;
Disqualifiers
Acute myocardial infarction (MI) in last 30 days before the treatment;
Aortic root anatomy not suitable for the implantation of the transcatheter aortic valve；
Complicated lesion of the aortic valve (aortic stenosis with severe regurgitation); moderate-severe mitral valve stenosis; severe mitral valve regurgitation; severe tricuspid valve regurgitation;
Previous implantation of heart valve at any position；
Trial design
Design model
Single group
Treatments tested in this trial
VitaFlow™ II Transcatheter Aortic Valve System
DeviceVitaFlow™ II Transcatheter Aortic Valve System contains a valve stent-VitaFlow™ Aortic Valve, a delivery system-VitaFlow™ Delivery System, loading tools, and a guide-wire
Treatment groups
145 Participants
are divided into 1 treatment groupGroup A: Single arm clinical investigationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of all-cause mortality at 12 months post implantation
Rate of all-cause mortality including cardiovascular and non-cardiovascular death
Time frame
12 months post implantationSecondary outcomes
1
Valve function-mean prosthetic valve gradient
Mean prosthetic valve gradient measured by transthoracic echocardiography (TTE)(in mmHg)
Time frame
at 30 days, 6 months, and 1 year post implantation2
Valve function- effective orifice area
Effective orifice area measured by transthoracic echocardiography (TTE)(in cm\^2)
Time frame
at 30 days, 6 months, and 1 year post implantation3
Valve function- degree of prosthetic valve regurgitation
Degree of prosthetic valve regurgitation including paravalvular leak and intravalvular regurgitation measured by transthoracic echocardiography (TTE)
Time frame
at 30 days, 6 months, and 1 year post implantation4
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
Time frame
at 30 days, 6 months, 1 year and annually up to 5 years post implantationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov