Aortic Valve StenosisNCT03575039
VitaFlowTM II Transcatheter Aortic Valve System Study
A study testing VitaFlow II Transcatheter Aortic Valve System in people with Aortic Valve Stenosis, run by Shanghai MicroPort CardioFlow Medtech Co., Ltd..
Trial summary
A prospective, single arm clinical investigation evaluating safety and effectiveness/performance of the Microport CardioFlow VitaFlowTM II - Transcatheter Aortic Valve System for the treatment of symptomatic severe aortic stenosis via transcatheter access in increased surgical risk patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve 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
- 178 participants
- Where
- No sites listed yet
- Study dates
- Aug 2018to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects of age > 18 years
- Subjects suffering from severe aortic valve stenosis, including bicuspid and tricuspid valves, defined as follows:
- High-gradient aortic stenosis (mean pressure gradient across aortic valve >40 mmHg or peak velocity ≥4.0 m/s.
- Subject has symptomatic valve stenosis presenting with NYHA ≥ Class II
- Subjects with a documented heart team agreement of increased surgical risk as described in the population
- ECG-gated multi-slice computed tomographic (MSCT) measurements determined an aortic annulus or supra-annular diameter ≥17 and ≤29mm. Findings of TTE, TEE and conventional aortography should be integrated in the anatomic assessment, when performed
- Patient deemed eligible by Centralised Case Review Committee (CRC) assessment recommends VitaFlow™ II Transcatheter Aortic Valve System implantation
- Subject can understand the purpose of the clinical investigation, has signed voluntary the informed consent form and is agreeing to the scheduled follow up requirements
Who cannot join
- Arterial aorto-iliac-femoral axis unsuitable for transfemoral access as assessed by conventional angiography and/or multi-detector computed tomographic angiography (access vessel diameter incompatible with a 19 to 22F OD delivery system with integrated sheath or 21 to 24F OD sheath)
- Aortic root anatomy condition or lesion preventing implantation or access to the aortic valve
- Non-calcific acquired aortic stenosis
- Native unicuspid aortic valve or congenital aortic abnormality (except for bicuspid aortic valve) not permitting TAVI
- Previous implantation of heart valve in any position
- Severe aortic regurgitation (>3+)
Show all 32Show fewer
- Severe mitral regurgitation (>3+)
- Severe tricuspid regurgitation (>3+)
- Severe left ventricular (LV) dysfunction (left ventricular ejection fraction < 30%)
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation
- Multi-vessel coronary artery disease with a Syntax score or residual Syntax score > 22 and/or unprotected left main coronary artery.
- Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
- Untreated cardiac conduction disease in need of pacemaker implantation
- Uncontrolled atrial fibrillation (resting heart rate > 120bpm)
- Active and/or suspicion of endocarditis or ongoing sepsis
- Blood dyscrasias defined as: leukopenia (WBC<1000 mm3), thrombocytopenia (PLT<50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states
- Evidence of an acute myocardial infarction ≤ 1 month (30 days) before signing informed consent
- Any need for emergency surgery
- Recent (within 6 months of signing informed consent) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
- Symptomatic carotid or vertebral artery disease or successful treatment of carotid stenosis within 30 days prior to signing informed consent
- Any active bleeding that precludes anticoagulation
- Liver failure (Child-C)
- End-stage renal disease requiring chronic dialysis or creatinine clearance < 20cc/min
- Pulmonary hypertension (systolic pressure >80mmHg)
- Severe chronic pulmonary disease (COPD) demonstrated by an expiratory volume (FEV1) < 750cc
- Refusal of blood transfusion
- A known hypersensitivity or contraindication to all anticoagulation/antiplatelet regimens (or inability to be anticoagulated for the index procedure), to nitinol, to dairy products, to polyethylene terephthalate (PET) or contrast media
- Any medical, social or psychological condition that in the opinion of the investigator precludes the subject from giving appropriate consent or adherence to the required follow up procedures
- Currently participating in another drug or device trial (excluding registries) for which the primary endpoint has not been assessed
- Estimated life expectancy of less than 12 months
- For female - pregnancy or intention to become pregnant prior to completion of all follow up procedures
- Inability to comply with the clinical investigation follow-up or other clinical investigation requirements
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The VITALE Study Evaluating Safety and Effectiveness/Performance of the Microport CardioFlow VitaFlow II - Transcatheter Aortic Valve System
A prospective, single arm clinical investigation evaluating safety and effectiveness/performance of the Microport CardioFlow VitaFlowTM II - Transcatheter Aortic Valve System for the treatment of symptomatic severe aortic stenosis via transcatheter access in increased surgical risk patients
Read the detailed description
This is a prospective, multicenter, single arm and controlled clinical investigation compared to recent historical results. The purpose is to evaluate the safety, performance and efficacy of the VitaflowTM II Transcatheter Aortic Valve system.
The entire system including valve system, delivery system and introducer system. We will implant the valve system into subjects and followed up them for 5 years after the procedure. This clinical trial will be conducted in 15 sites in Europe.
- Conditions
- Aortic Valve 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 II Delivery System and a Introducer set
| Study group | Role | What they receive |
|---|---|---|
| Single arm clinical investigation | Experimental | Subjects in experimental group will be implanted 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
all-cause mortality including cardiovascular and non-cardiovascular
Measured: 12 months post implantation
Secondary outcomes (18)
Rate of Composite of all-cause mortality and disabling stroke
defined as the ratio of all-cause dead and disabled subjects to total subjects at each time point
Measured: at 30 days, 6 months,12 months, 2, 3, 4 and 5 years post implantation
Rate of stroke (disabling and non-disabling)
defined as the ratio of stroke subjects (disabling and non-disabling) to total subjects at each time point
Measured: at 30 days, 6 months,12 months, 2, 3, 4 and 5 years post-implantation
Initial success
defined as absence of procedural mortality AND correct positioning of a single VitaFlowTM Aortic Valve into the proper anatomical location AND absence of patient / VitaFlowTM Aortic Valve mismatch AND mean aortic valve gradient less than (<) 20 mmHg or peak velocity less than (<) 3m/s, AND absence of moderate or severe prosthetic valve regurgitation
Measured: within 30 days post-implantation
Recapture success rate (when attempted)
defined as VitaFlowTM Aortic Valve is fully re-sheathed into the VitaFlowTM II delivery system, as verified by fluoroscopy
Measured: at 1st day post-implantation
Successful insertion
navigation and functioning of ALL features for the VitaFlowTM II delivery system, deployment and implantation of the VitaFlowTM aortic valve and subsequent retrieval of the VitaFlowTM II delivery system
Measured: at 1st day post-implantation
Valve function
Evaluating valva function(including valve position, morphology, function and rate of valvular stenosis, valve regurgitation, orifice area and pressure gradient and paravalvular leakage) at each time point.
Measured: at 30 days, 6 and 12 months and 2, 3, 4, 5 years post-implantation
Changes in quality of life KCCQ
an overall summary score can be derived from the physical function, symptom (frequency and severity), social function and quality of life domains. For each domain, the validity, reproducibility, responsiveness and interpretability have been independently established. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Measured: at 30 days, 6 and 12 months and 2, 3, 4, 5 years post-implantation compared to baseline
Changes in quality of life EQ-5D-5L
Use the questions and score system to evaluate life quality of subjects at each The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Measured: at 30 days, 6 and 12 months and 2, 3, 4, 5 years post-implantation compared to baseline
Changes in frailty (KATZ questionnaire)
Assesses the ability of patients to conduct activities of daily living by questions in KATZ questionnaire. We use dependent(0 points) and independent(1 points) to evaluate bathing, dressing, toileting, transferring, contience and feeding activities of subjects. Total score is 6 points, the higher the score, the more indepent of subjects.
Measured: at 30 days, 12 months, 1, 2, 3, 4 and 5 years post-implantation compared to baseline
Changes in cardiac function
defined as changes in cardiac function at each time point according to the NYHA Classification Scheme compared to baseline
Measured: at discharge, 30 days, 6 and 12 months and 2, 3, 4, 5 years post-implantation
Rate of all-cause mortality
all-cause mortality including cardiovascular and non-cardiovascular
Measured: at 30 days, 6 months and 2, 3, 4, 5 years post-implantation
Rate of main adverse cardiac and cerebral events (MACCE)
Rate of main adverse cardiac and cerebral events (MACCE) including disabling stroke, myocardial infarction, open surgery, and new permanent pacemaker at each time point
Measured: at 30 days, 6 and 12 months and 2, 3, 4, 5 years post-implantation
Rate of life-threatening, disabling or severe bleeding (BARC 3 to 5)
BARC 3 to 5 defined as in BARC definition in annex of the protocol
Measured: at 30 days, 6 and 12 months and 2, 3, 4, 5 years post-implantation
Rate of acute kidney injury network stage 2 and 3 or renal alternation therapy
renal alternation therapy including haemodialysis, peritoneal dialysis and hemofiltration
Measured: at 30 days, 6 and 12 months and 2 to 5 years
Rate of implant related new and/or worsened conduction disturbances and arrhythmias, and occurrence of new permanent pacemaker implantation
Rate of implant related new and/or worsened conduction disturbances and arrhythmias, and occurrence of new permanent pacemaker implantation
Measured: at 30 days, 6 and 12 months and 2, 3, 4, 5 years post-implantation
Rate of major vascular complications
vascular complications defined according to VARC2 definitions
Measured: at 30 days, 6 and 12 months and 2, 3, 4, 5 years post-implantation
Rate of the occurrence of hospitalization
Rate of the occurrence of hospitalization for valve-related symptoms or worsening congestive heart failure
Measured: at 6, 12 months, and 2, 3, 4, 5 years post-implantation
Rate of other TAVI-related adverse events
Rate of other TAVI-related adverse events (conversion to open surgery, unplanned used of cardiopulmonary bypass, coronary obstruction requiring intervention, ventricular septal perforation, mitral valve apparatus damage or dysfunction, cardiac tamponade, endocarditis, valve thrombosis, valve mal-positioning, TAV-in-TAV deployment, structural valve deterioration, valve related dysfunction or events requiring repeat procedure [BAV, TAVR, SAVR]
Measured: at 30 days, 6 and 12 months and at 2, 3, 4 and 5 years post implantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study startAug 2018 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve 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
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicolo Piazza, Principal investigator, Bern Unversity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575039
- Sponsor's protocol ID
- Valve-2018-01
- Status last verified
- Jun 2018
- First submitted
- 31 May 2018
- Last updated
- 2 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is an internal clinical research, the detail data won't be shared with other researcher before our product come into the market.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The VITALE Study Evaluating Safety and Effectiveness/Performance of the Microport CardioFlow VitaFlow II - Transcatheter Aortic Valve System
- ClinicalTrials.gov ID
- NCT03575039
- Acronym / sponsor ID
- Valve-2018-01
- Conditions
- Aortic Valve Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2018 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 2 Jul 2018 (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.
A prospective, single arm clinical investigation evaluating safety and effectiveness/performance of the Microport CardioFlow VitaFlowTM II - Transcatheter Aortic Valve System for the treatment of symptomatic severe aortic stenosis via transcatheter access in increased surgical risk patients
Detailed description
This is a prospective, multicenter, single arm and controlled clinical investigation compared to recent historical results. The purpose is to evaluate the safety, performance and efficacy of the VitaflowTM II Transcatheter Aortic Valve system.
The entire system including valve system, delivery system and introducer system. We will implant the valve system into subjects and followed up them for 5 years after the procedure. This clinical trial will be conducted in 15 sites in Europe.
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 the VitaFlow II Transcatheter Aortic Valve System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects of age > 18 years
- Subjects suffering from severe aortic valve stenosis, including bicuspid and tricuspid valves, defined as follows:
- High-gradient aortic stenosis (mean pressure gradient across aortic valve >40 mmHg or peak velocity ≥4.0 m/s.
- Subject has symptomatic valve stenosis presenting with NYHA ≥ Class II
- Subjects with a documented heart team agreement of increased surgical risk as described in the population
Key exclusion criteria (32 listed)
- Arterial aorto-iliac-femoral axis unsuitable for transfemoral access as assessed by conventional angiography and/or multi-detector computed tomographic angiography (access vessel diameter incompatible with a 19 to 22F OD delivery system with integrated sheath or 21 to 24F OD sheath)
- Aortic root anatomy condition or lesion preventing implantation or access to the aortic valve
- Non-calcific acquired aortic stenosis
- Native unicuspid aortic valve or congenital aortic abnormality (except for bicuspid aortic valve) not permitting TAVI
- Previous implantation of heart valve in any position
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 II Delivery System and a Introducer set | Device | Single arm clinical investigation |
Primary outcome
Rate of all-cause mortality at 12 months post implantation
Time frame: 12 months post implantation
all-cause mortality including cardiovascular and non-cardiovascular
18 secondary outcomes
Rate of Composite of all-cause mortality and disabling stroke
Time frame: at 30 days, 6 months,12 months, 2, 3, 4 and 5 years post implantation
Rate of stroke (disabling and non-disabling)
Time frame: at 30 days, 6 months,12 months, 2, 3, 4 and 5 years post-implantation
Initial success
Time frame: within 30 days post-implantation
Recapture success rate (when attempted)
Time frame: at 1st day post-implantation
Successful insertion
Time frame: at 1st day post-implantation
Valve function
Time frame: at 30 days, 6 and 12 months and 2, 3, 4, 5 years post-implantation
Changes in quality of life KCCQ
Time frame: at 30 days, 6 and 12 months and 2, 3, 4, 5 years post-implantation compared to baseline
Changes in quality of life EQ-5D-5L
Time frame: at 30 days, 6 and 12 months and 2, 3, 4, 5 years post-implantation compared to baseline
Changes in frailty (KATZ questionnaire)
Time frame: at 30 days, 12 months, 1, 2, 3, 4 and 5 years post-implantation compared to baseline
Changes in cardiac function
Time frame: at discharge, 30 days, 6 and 12 months and 2, 3, 4, 5 years post-implantation
Rate of all-cause mortality
Time frame: at 30 days, 6 months and 2, 3, 4, 5 years post-implantation
Rate of main adverse cardiac and cerebral events (MACCE)
Time frame: at 30 days, 6 and 12 months and 2, 3, 4, 5 years post-implantation
Rate of life-threatening, disabling or severe bleeding (BARC 3 to 5)
Time frame: at 30 days, 6 and 12 months and 2, 3, 4, 5 years post-implantation
Rate of acute kidney injury network stage 2 and 3 or renal alternation therapy
Time frame: at 30 days, 6 and 12 months and 2 to 5 years
Rate of implant related new and/or worsened conduction disturbances and arrhythmias, and occurrence of new permanent pacemaker implantation
Time frame: at 30 days, 6 and 12 months and 2, 3, 4, 5 years post-implantation
Rate of major vascular complications
Time frame: at 30 days, 6 and 12 months and 2, 3, 4, 5 years post-implantation
Rate of the occurrence of hospitalization
Time frame: at 6, 12 months, and 2, 3, 4, 5 years post-implantation
Rate of other TAVI-related adverse events
Time frame: at 30 days, 6 and 12 months and at 2, 3, 4 and 5 years post implantation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
- Individual participant dataSharing planned: No. This is an internal clinical research, the detail data won't be shared with other researcher before our product come into the market.
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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. This study is not recruiting at the moment.
Nicolo Piazza principal investigator
Bern Unversity Hospital
Questions about this trial
What is this clinical trial studying?
A study testing VitaFlow II Transcatheter Aortic Valve System in people with Aortic Valve Stenosis, run by Shanghai MicroPort CardioFlow Medtech Co., Ltd..
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 8 inclusion and 32 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: status not confirmed, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ada Wang (86-021-38954600-7814, wanglu2@microport.comwajin), 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?
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 2 Jul 2018.