Aortic StenosisNCT04414878
VitaFlow™ II Transcatheter Aortic Valve System Pre-market Trial
A study testing VitaFlow™ II Transcatheter Aortic Valve System in people with Aortic Stenosis, run by Shanghai MicroPort CardioFlow Medtech Co., Ltd. at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- VitaFlow™ II Transcatheter Aortic Valve System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 4 sitesChina
- Study dates
- 31 Jan 2018to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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 enroll in the study by signing a patient informed consent and agreeing to the scheduled follow up requirement.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Fuwai Hospital
Beijing, Beijing Municipality
Yongjian Wu, Prof, 13701387189
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
Mao Chen, Prof, 18980602046
- Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
Jian-An Wang, Prof, 13805786328
- Recruiting
Zhongshan Hospital
Shanghai, Shanghai Municipality
Junbo Ge, Prof, 13901977506
About this study
Official title: 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.
Read the 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.
- Conditions
- Aortic Stenosis
- Being tested
- VitaFlow™ II Transcatheter Aortic Valve System
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitaFlow™ II Transcatheter Aortic Valve SystemDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Single arm clinical investigation | Experimental | Subjects in experimental group will be implanted with the VitaFlow™ II Transcatheter Aortic Valve System Receives: Device: VitaFlow™ II Transcatheter Aortic Valve System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of all-cause mortality at 12 months post implantation
Rate of all-cause mortality including cardiovascular and non-cardiovascular death
Measured: 12 months post implantation
Secondary outcomes (10)
Valve function-mean prosthetic valve gradient
Mean prosthetic valve gradient measured by transthoracic echocardiography (TTE)(in mmHg)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: at immediate post implantation
Rate of procedure success
Rate of procedure success, assessed by the device success and the peri-procedural complications
Measured: at immediate post implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start31 Jan 2018
- Primary completion31 Jan 2022 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414878
- Sponsor's protocol ID
- SUPERIOR-2017
- Status last verified
- May 2020
- First submitted
- 27 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen S, Zhan Z, Chen D, Jin Q, Zhang Y, Zhang X, Pan W, Zhou D, Ge J. Two-year outcomes of transcatheter aortic valve replacement with the vitaflow libertyTM system in high-surgical-risk patients with severe aortic stenosis. J Cardiothorac Surg. 2026 Jun 15. doi: 10.1186/s13019-026-04317-0. Online ahead of print.
PubMed 42298602
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04414878
- Acronym / sponsor ID
- SUPERIOR-2017
- Conditions
- Aortic Stenosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm clinical investigation | Experimental | Device: VitaFlow™ II Transcatheter Aortic Valve SystemSubjects in experimental group will be implanted with the VitaFlow™ II Transcatheter Aortic Valve System |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VitaFlow™ II Transcatheter Aortic Valve SystemVitaFlow™ II Transcatheter Aortic Valve System contains a valve stent-VitaFlow™ Aortic Valve, a delivery system-VitaFlow™ Delivery System, loading tools, and a guide-wire | Device | Single arm clinical investigation |
Primary outcome
Rate of all-cause mortality at 12 months post implantation
Time frame: 12 months post implantation
Rate of all-cause mortality including cardiovascular and non-cardiovascular death
10 secondary outcomes
Valve function-mean prosthetic valve gradient
Time frame: at 30 days, 6 months, and 1 year post implantation
Valve function- effective orifice area
Time frame: at 30 days, 6 months, and 1 year post implantation
Valve function- degree of prosthetic valve regurgitation
Time frame: at 30 days, 6 months, and 1 year post implantation
Rate of safety events according to VARC2
Time frame: at 30 days, 6 months, 1 year and annually up to 5 years post implantation
Rate of other TAVI-related complications
Time frame: at 30 days, 6 months, 1 year and annually up to 5 years post implantation
Rate of major adverse cardiac and cerebrovascular events(MACCE)
Time frame: at 30 days, 6 months, 1 year and annually up to 5 years post implantation
Rate of device success
Time frame: at immediate post implantation
Rate of balloon pre-dilation success
Time frame: at immediate post implantation
Rate of balloon post-dilation success
Time frame: at immediate post implantation
Rate of procedure success
Time frame: at immediate post implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Derived from this study: PubMed 42298602Chen S, Zhan Z, Chen D, Jin Q, Zhang Y, Zhang X, Pan W, Zhou D, Ge J. Two-year outcomes of transcatheter aortic valve replacement with the vitaflow libertyTM system in high-surgical-risk patients with severe aortic stenosis. J Cardiothorac Surg. 2026 Jun 15. doi: 10.1186/s13019-026-04317-0. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VitaFlow™ II Transcatheter Aortic Valve System in people with Aortic Stenosis, run by Shanghai MicroPort CardioFlow Medtech Co., Ltd. at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bi Jie ((86)(21)38954600, jbi@microport.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of all-cause mortality at 12 months post implantation (time frame: 12 months post implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04414878, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.