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New treatment option for Aortic Stenosis
Official title VitaFlow™ II Transcatheter Aortic Valve System Pre-market Trial
ClinicalTrials.gov ID: NCT04414878
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 70 and older
You may be able to join if
- 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...
- NYHA≥II class;
- Estimated life-expectancy\>12 months after implantation of the prosthetic valve;
- Anatomically suitable for the transcatheter aortic valve implantation procedure;
You likely can't join if
- 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...
- Previous implantation of heart valve at any position；
- Hemodynamic instability requiring mechanical hemodynamic support devices;
- Need for emergency surgery for any reason;
See the full eligibility criteria
- 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;
- Anatomically suitable for the transcatheter aortic valve implantation procedure;
- 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...
- 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；
- Hemodynamic instability requiring mechanical hemodynamic support devices;
- Need for emergency surgery for any reason;
- Hypertrophic cardiomyopathy with obstruction;
- Severe left ventricular dysfunction with left ventricular ejection fraction (LVEF) \< 20%;Severe right ventricular dysfunction;
- Active peptic ulcer or upper gastro-intestinal bleeding within the past 3 months;
- Known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens, to nitinol, contrast media or other relevant elements.
- Congenital aortic valve stenosis or unicuspid aortic valve;
- Vascular diseases or anatomical condition preventing the device access;
- Active endocarditis or other active infections at the time of treatment;
- Participating in another trial and the primary endpoint is not achieved.
- Inability to comply with the clinical investigation follow-up or other requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuan, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 70 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Shanghai, Shanghai Municipality, China; Chengdu, Sichuan, China; Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.