Aortic Valve DiseaseVITALNCT05977257
VitaFlow® Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up （VITAL）
An observational study of Aortic Valve Disease and Aortic Valve Stenosis, run by Shanghai MicroPort CardioFlow Medtech Co., Ltd. at 4 sites in China.
Trial summary
This study is an observational study to evaluate the long-term safety and effectiveness of the valve system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Disease, Aortic Valve Stenosis
- What is being tested?
- VitaFlow® Transcatheter Aortic Valve Replacement System
- Type of treatment
- Medical device
- How many people
- 89 participants
- Where
- 4 sitesChina
- Study dates
- 30 Jul 2023to 30 Oct 2028
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have participated in the VitaFlow® transcatheter aortic valve system pre-market trial
Who may be able to join
- Must meet 1, 2, 3, 4 or 1, 5 to be selected:
- Patients who have participated in the VitaFlow® transcatheter aortic valve system pre-market trial in the 4 designated research institutions*;
- Be able to get in touch with the patient or his legal guardian/relative;
- Patients who can understand the purpose and nature of the follow-up of this study, and are willing to cooperate with the follow-up and provide follow-up information;
- Sign the informed consent form;
- Patients who are known to have died.
- 4 research institutions: Zhongshan Hospital Fudan University, Second Affiliated Hospital of Zhejiang University School of Medicine, West China Hospital of Sichuan University and Fuwai Hospital.
Who cannot join
- Participate in clinical trials of other drugs or medical devices and have not yet reached the primary endpoint;
- The investigator judges that the patient's compliance is poor and the study cannot be completed as required.
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
Fuwai CVD Hospital of Chinese Academy of Medical Sciences
Beijing
Yongjian Wu
West China Hospital, Sichuan University
Chengdu
Yuan Feng
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou
Jianan Wang
Zhongshan Hospital Fudan University
Shanghai
Daxin Zhou
Daxin Zhou
About this study
This study is an observational study to evaluate the long-term safety and effectiveness of the valve system.
Read the detailed description
This study is an observational study, for who have joined the VitaFlow® Catheter Aortic Valve System pre-market trial (Protocol No. valve -2014-04) in 4 designated research institutions, and follow-up from 6 to 10 years after the procedure, To evaluate the long-term safety and effectiveness of the valve system.
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis
- Being tested
- VitaFlow® Transcatheter Aortic Valve Replacement System
- Medical subject headings
- Aortic Valve Disease, 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 Replacement SystemDevice
This study is an observational study, for who have joined the VitaFlow® Catheter Aortic Valve System pre-market trial
| Study group | Role | What they receive |
|---|---|---|
| Non Interventional long term safety follow up | Non Interventional long term safety follow up Receives: Device: VitaFlow® Transcatheter Aortic Valve Replacement System |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality
rate of all cause mortality
Measured: 7years after the operation
Secondary outcomes (17)
Cardiac death
rate of Cardiac death
Measured: 6 years, 7 years, 8 years, 9 years and 10 years after the operation
Stroke
rate of stroke
Measured: 6 years, 7 years, 8 years, 9 years and 10 years after the operation
valve-related rehospitalization
rate of valve-related rehospitalization
Measured: 6 years, 7 years, 8 years, 9 years and 10 years after the operation
Serious Adverse Event
rate of Serious Adverse Event
Measured: 6 years, 7 years, 8 years, 9 years and 10 years after the operation
Blood pressure
Systolic and Diastolic Blood Pressure
Measured: 6 years, 7 years, 8 years, 9 years and 10 years after the operation
The 12-Item Short Form Health Survey (SF-12)
Scores range from 0 to 100, higher scores are better
Measured: 6years, 7years, 8 years, 9 years and 10 years after the operation
Mean transvalvular pressure gradient
Transthoracic Echocardiogram test
Measured: 7years,and 10 years after the operation
Effective orifice area
Transthoracic Echocardiogram test
Measured: 7years,and 10 years after the operation
Peak velocity
Transthoracic Echocardiogram test
Measured: 7years,and 10 years after the operation
class of Paravalvular leak
Transthoracic Echocardiogram test
Measured: 7years,and 10 years after the operation
class of Aortic regurgitation
Transthoracic Echocardiogram test
Measured: 7years,and 10 years after the operation
New York Heart Association Class for heart function
NYHA class
Measured: 7years,and 10 years after the operation
Kansas City Cardiomyopathy Questionnaire
Kansas City Cardiomyopathy Questionnaire(score 0-100), higher scores are better
Measured: 7years,and 10 years after the operation
Natriuretic peptide tests ( NT Pro-BNP or BNP)
blood test
Measured: 7years,and 10 years after the operation
moderate and severe structural valve deterioration SVD
Transthoracic Echocardiogram test
Measured: 7years,and 10 years after the operation
bioprosthetic valve failure，BVF
Transthoracic Echocardiogram test
Measured: 7years,and 10 years after the operation
All cause mortality
rate of all cause mortality
Measured: 6 years, 8 years, 9 years and 10 years after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start30 Jul 2023 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 89 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daxin Zhou, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977257
- Sponsor's protocol ID
- VITAL-2023-192R
- Acronym
- VITAL
- Status last verified
- Jul 2023
- First submitted
- 10 Jul 2023
- Last updated
- 4 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VitaFlow® Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up （VITAL）
- ClinicalTrials.gov ID
- NCT05977257
- Acronym / sponsor ID
- VITAL / VITAL-2023-192R
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 89 participants (estimated)
- Lead sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jul 2023 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 4 Aug 2023 (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 study is an observational study to evaluate the long-term safety and effectiveness of the valve system.
Detailed description
This study is an observational study, for who have joined the VitaFlow® Catheter Aortic Valve System pre-market trial (Protocol No. valve -2014-04) in 4 designated research institutions, and follow-up from 6 to 10 years after the procedure, To evaluate the long-term safety and effectiveness of the valve system.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non Interventional long term safety follow up | – | Device: VitaFlow® Transcatheter Aortic Valve Replacement SystemNon Interventional long term safety follow up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have participated in the VitaFlow® transcatheter aortic valve system pre-market trial
Key inclusion criteria (7 listed)
- Must meet 1, 2, 3, 4 or 1, 5 to be selected:
Key exclusion criteria (2 listed)
- Participate in clinical trials of other drugs or medical devices and have not yet reached the primary endpoint;
- The investigator judges that the patient's compliance is poor and the study cannot be completed as required.
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 Replacement SystemThis study is an observational study, for who have joined the VitaFlow® Catheter Aortic Valve System pre-market trial | Device | Non Interventional long term safety follow up |
Primary outcome
All cause mortality
Time frame: 7years after the operation
rate of all cause mortality
17 secondary outcomes
Cardiac death
Time frame: 6 years, 7 years, 8 years, 9 years and 10 years after the operation
Stroke
Time frame: 6 years, 7 years, 8 years, 9 years and 10 years after the operation
valve-related rehospitalization
Time frame: 6 years, 7 years, 8 years, 9 years and 10 years after the operation
Serious Adverse Event
Time frame: 6 years, 7 years, 8 years, 9 years and 10 years after the operation
Blood pressure
Time frame: 6 years, 7 years, 8 years, 9 years and 10 years after the operation
The 12-Item Short Form Health Survey (SF-12)
Time frame: 6years, 7years, 8 years, 9 years and 10 years after the operation
Mean transvalvular pressure gradient
Time frame: 7years,and 10 years after the operation
Effective orifice area
Time frame: 7years,and 10 years after the operation
Peak velocity
Time frame: 7years,and 10 years after the operation
class of Paravalvular leak
Time frame: 7years,and 10 years after the operation
class of Aortic regurgitation
Time frame: 7years,and 10 years after the operation
New York Heart Association Class for heart function
Time frame: 7years,and 10 years after the operation
Kansas City Cardiomyopathy Questionnaire
Time frame: 7years,and 10 years after the operation
Natriuretic peptide tests ( NT Pro-BNP or BNP)
Time frame: 7years,and 10 years after the operation
moderate and severe structural valve deterioration SVD
Time frame: 7years,and 10 years after the operation
bioprosthetic valve failure，BVF
Time frame: 7years,and 10 years after the operation
All cause mortality
Time frame: 6 years, 8 years, 9 years and 10 years after the operation
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 Aug 2023.
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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.
Daxin Zhou principal investigator
Fudan University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Disease and 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 7 inclusion and 2 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: opening soon, as of the sponsor's last update on 4 Aug 2023. 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 JIATONG ZHANG (+8617797187661, JiaTong.Zhang@microport.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: 7years after the operation). 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 4 Aug 2023.