Aortic Valve StenosisNCT04655742
VitaFlow™ Transcatheter Aortic Valve System Pre-market Trial
A study testing VitaFlow™ Transcatheter Aortic Valve System in people with Aortic Valve 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™ 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 Valve Stenosis
- What is being tested?
- VitaFlow™ Transcatheter Aortic Valve System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesChina
- Study dates
- 27 Jun 2014to 31 Dec 2021
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Fuwai Hospital
Beijing, Beijing Municipality
West China Hospital of Sichuan University
Chengdu, Sichuan
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Aortic Valve Stenosis
- Being tested
- VitaFlow™ 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™ Transcatheter Aortic Valve SystemDevice
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
| Study group | Role | What they receive |
|---|---|---|
| single arm, treatment group | Experimental | Subjects in the treatment group will be implanted with the VitaFlow™ Transcatheter Aortic Valve System Receives: Device: VitaFlow™ Transcatheter Aortic Valve System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of device success-Phase I
Measured: at immediate post-procedure
All-cause mortality at 12 months post implantation-Phase II
Measured: at 12 months post-procedure
Secondary outcomes (7)
Rate of major adverse events -Phase I
Measured: 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)
Measured: at immediate post-procedure, discharge, 30 days, 6 months, 1 year and annually up to 5 years post implantation
Heart function(NYHA)-Phase II
Measured: 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
Measured: at immediate, 30 days, 1 year and annually up to 5 years post implantation
Rate of major cardiovascular and cerebrovascular events(MACCE)-Phase II
Measured: at immediate, 30 days, 1 year and annually up to 5 years post implantation
Rate of balloon pre-dilatation success-Phase II
Measured: at immediate post implantation
Rate of balloon post-dilatation success-Phase II
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 posted7 Dec 2020
- Study start27 Jun 2014
- Primary completion6 Sep 2017
- Study completion31 Dec 2021 (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
- 120 participants (actual)
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
- NCT04655742
- Sponsor's protocol ID
- valve-2014-04
- Status last verified
- Nov 2020
- First submitted
- 30 Nov 2020
- Last updated
- 7 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04655742
- Acronym / sponsor ID
- valve-2014-04
- Conditions
- Aortic Valve Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Jun 2014 (actual)
- Primary completion
- 6 Sep 2017 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 7 Dec 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™ Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.
Detailed description
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.
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, treatment group | Experimental | Device: VitaFlow™ Transcatheter Aortic Valve SystemSubjects in the treatment group will be implanted with the VitaFlow™ 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 (8 listed)
- 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;
Key exclusion criteria (19 listed)
- 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;
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™ Transcatheter Aortic Valve SystemVitaFlow™ 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 | Device | single arm, treatment group |
Primary outcome
Rate of device success-Phase I
Time frame: at immediate post-procedure
All-cause mortality at 12 months post implantation-Phase II
Time frame: at 12 months post-procedure
7 secondary outcomes
Rate of major adverse events -Phase I
Time frame: at 30 days post implantation
Hemodynamic performance-Phase II
Time frame: at immediate post-procedure, discharge, 30 days, 6 months, 1 year and annually up to 5 years post implantation
Heart function(NYHA)-Phase II
Time frame: 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
Time frame: at immediate, 30 days, 1 year and annually up to 5 years post implantation
Rate of major cardiovascular and cerebrovascular events(MACCE)-Phase II
Time frame: at immediate, 30 days, 1 year and annually up to 5 years post implantation
Rate of balloon pre-dilatation success-Phase II
Time frame: at immediate post implantation
Rate of balloon post-dilatation success-Phase II
Time frame: at immediate post implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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™ Transcatheter Aortic Valve System in people with Aortic Valve 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 8 inclusion and 19 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 7 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of device success-Phase I (time frame: at immediate post-procedure). The study lists 2 primary outcomes in all. 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 7 Dec 2020.