Valvular Heart DiseaseNCT05044338
Study on Standard Evaluation System and Optimal Treatment Path of Senile Valvular Heart Disease
An observational study of Valvular Heart Disease, run by Yongjian Wu at 1 site in China.
Trial summary
The key technology research and standard evaluation system of elderly heart valve disease evaluation is to further establish a domestic multi center and large sample full information big data platform of elderly heart valve disease based on the previous Chinese elderly valve disease cohort and clinical research… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Valvular Heart Disease
- What is being tested?
- imaging
- How many people
- 6,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to Nov 2023
- Phase
- Observational
- 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 65 years and older
- All sexes
- Older adult
Study population: Inpatients in each research center
Who may be able to join
- Patients with heart valve disease who are ≥ 65 years old and diagnosed by echocardiography meet the requirements
- One of the following criteria:
- (1)Severe mitral stenosis: valve orifice area < 1.0cm2;
- (2)Severe mitral regurgitation: constriction neck width ≥ 7mm, or regurgitation per beat (regurgitation volume)≥ 60ml, or reflux beam area / left atrial area > 50%; Or effective reflux port area (eroa) ≥ 0.4cm2;
- (3)Severe aortic stenosis: mean cross valve pressure difference ≥ 40mmhg, or maximum jet velocity ≥ 4m / s, orValve orifice area < 1.0cm2, it should be differentiated from left ventricular outflow tract stenosis;
- (4)Severe aortic regurgitation: constriction neck width > 6mm, or each pulsation regurgitation ≥ 60ml, or regurgitation Flow fraction ≥ 50%, or jet width ≥ 65% of left ventricular outflow tract, or effective reflux orifice area (eroa) ≥0.3cm2；
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- (5)Severe tricuspid stenosis: mean cross valve pressure difference ≥ 5mmhg;
- (6)Severe tricuspid regurgitation: constriction neck width ≥ 7mm, or effective regurgitation orifice area (eroa)≥0.4cm2；
- (7)Severe pulmonary stenosis: the forward blood flow velocity is ≥ 4m / s, which should be differentiated from right ventricular outflow tract stenosis; Severe pulmonary valve regurgitation: massive regurgitation, wide constriction neck
Who cannot join
- Patients unwilling to accept registration and follow-up;
- Patients with mental illness who cannot cooperate with information collection and follow-up
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital, National Center for Cardiovascular Diseases，Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100037
haiyan xu, doctor, +86 13681012249, xuhaiyan@fuwaihospital.org
yongjian wu, doctor, +86 13701387189, fuwaihospital@hotmail.com
About this study
Official title: China Degenerative Valve Disease II Cohort Study (China-DVD2 Study)
The key technology research and standard evaluation system of elderly heart valve disease evaluation is to further establish a domestic multi center and large sample full information big data platform of elderly heart valve disease based on the previous Chinese elderly valve disease cohort and clinical research platform and the national valve disease surgery data platform.
Read the detailed description
Establish clinical and Imaging Database
- Conditions
- Valvular Heart Disease
- Being tested
- imaging
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imagingDiagnostic test
(1) Build the first full information big data cloud platform for diagnosis, treatment and clinical research of senile valvular disease in China (2) To establish a cohort of elderly patients with valvular disease in China and a complete database covering clinical information, functional, imaging evaluation, treatment and follow-up; (3) To analyze the clinical characteristics, functional status and imaging characteristics of senile valvular disease in China, and to understand the current situation of diagnosis and treatment; To establish a whole process standardized comprehensive evaluation system of clinical indicators of senile valvular disease combined with a variety of imaging for Chinese people.
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
all-cause mortality
Measured: Time Frame: 2years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start1 Sep 2021
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Valvular Heart 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
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yongjian Wu
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Yongjian Wu, China National Center for Cardiovascular Diseases
- Investigators
- yongjian wu, doctor, Study chair, Fuwai Hospital, National Center for Cardiovascular Diseases，Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044338
- Sponsor's protocol ID
- 2020YFC2008100
- Status last verified
- Sep 2021
- First submitted
- 12 Sep 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mao Y, Liu Y, Zhai M, Jin P, Chen F, Zhang G, Wei L, Liu J, Guo Y, Wu Y, Yang J. Predictors of Paravalvular Leakage After Transcatheter Aortic Valve Replacement in Patients With BAV: A Machine Learning Model. JACC Adv. 2026 Feb;5(2):102566. doi: 10.1016/j.jacadv.2025.102566. Epub 2026 Jan 20.
PubMed 41558358Mao Y, Liu Y, Zhai M, Jin P, Li W, Chen F, Yang Y, Zhang G, Liu J, Guo Y, Pan X, Wu Y, Yang J. Clinical significance of machine learning algorithm in predicting PPM during TAVR in small annuli. Cardiovasc Interv Ther. 2026 Apr;41(2):402-413. doi: 10.1007/s12928-025-01215-5. Epub 2026 Jan 5.
PubMed 41491442Mao Y, Liu Y, Zhai M, Jin P, Li W, Dong X, Chen F, Wang X, Wang Y, Zhang G, Li H, Yang Y, Zhang H, Liu J, Guo Y, Wu Y, Xue Y, Zhang J, Frangi A, Yang J. Precision TAVR quantification- AI-accelerated TAVR planning reduces assessment time by 80% in bicuspid aortic stenosis. Eur Heart J Imaging Methods Pract. 2025 Dec 5;3(4):qyaf153. doi: 10.1093/ehjimp/qyaf153. eCollection 2025 Oct.
PubMed 41445779
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Degenerative Valve Disease II Cohort Study (China-DVD2 Study)
- ClinicalTrials.gov ID
- NCT05044338
- Acronym / sponsor ID
- 2020YFC2008100
- Conditions
- Valvular Heart Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Yongjian WuOther government
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 14 Sep 2021 (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.
The key technology research and standard evaluation system of elderly heart valve disease evaluation is to further establish a domestic multi center and large sample full information big data platform of elderly heart valve disease based on the previous Chinese elderly valve disease cohort and clinical research platform and the national valve disease surgery data platform.
Detailed description
Establish clinical and Imaging Database
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Inpatients in each research center
Key inclusion criteria (9 listed)
- Patients with heart valve disease who are ≥ 65 years old and diagnosed by echocardiography meet the requirements
- (1)Severe mitral stenosis: valve orifice area < 1.0cm2;
- (2)Severe mitral regurgitation: constriction neck width ≥ 7mm, or regurgitation per beat (regurgitation volume)≥ 60ml, or reflux beam area / left atrial area > 50%; Or effective reflux port area (eroa) ≥ 0.4cm2;
- (3)Severe aortic stenosis: mean cross valve pressure difference ≥ 40mmhg, or maximum jet velocity ≥ 4m / s, orValve orifice area < 1.0cm2, it should be differentiated from left ventricular outflow tract stenosis;
- (4)Severe aortic regurgitation: constriction neck width > 6mm, or each pulsation regurgitation ≥ 60ml, or regurgitation Flow fraction ≥ 50%, or jet width ≥ 65% of left ventricular outflow tract, or effective reflux orifice area (eroa) ≥0.3cm2；
Key exclusion criteria (2 listed)
- Patients unwilling to accept registration and follow-up;
- Patients with mental illness who cannot cooperate with information collection and follow-up
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 |
|---|---|---|
| imaging(1) Build the first full information big data cloud platform for diagnosis, treatment and clinical research of senile valvular disease in China (2) To establish a cohort of elderly patients with valvular disease in China and a complete database covering clinical information, functional, imaging evaluation, treatment and follow-up; (3) To analyze the clinical characteristics, functional status and imaging characteristics of senile valvular disease in China, and to understand the current situation of diagnosis and treatment; To establish a whole process standardized comprehensive evaluation system of clinical indicators of senile valvular disease combined with a variety of imaging for Chinese people. | Diagnostic test | – |
Primary outcome
all-cause mortality
Time frame: Time Frame: 2years
all-cause mortality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Derived from this study: PubMed 41558358Mao Y, Liu Y, Zhai M, Jin P, Chen F, Zhang G, Wei L, Liu J, Guo Y, Wu Y, Yang J. Predictors of Paravalvular Leakage After Transcatheter Aortic Valve Replacement in Patients With BAV: A Machine Learning Model. JACC Adv. 2026 Feb;5(2):102566. doi: 10.1016/j.jacadv.2025.102566. Epub 2026 Jan 20.
- Derived from this study: PubMed 41491442Mao Y, Liu Y, Zhai M, Jin P, Li W, Chen F, Yang Y, Zhang G, Liu J, Guo Y, Pan X, Wu Y, Yang J. Clinical significance of machine learning algorithm in predicting PPM during TAVR in small annuli. Cardiovasc Interv Ther. 2026 Apr;41(2):402-413. doi: 10.1007/s12928-025-01215-5. Epub 2026 Jan 5.
- Derived from this study: PubMed 41445779Mao Y, Liu Y, Zhai M, Jin P, Li W, Dong X, Chen F, Wang X, Wang Y, Zhang G, Li H, Yang Y, Zhang H, Liu J, Guo Y, Wu Y, Xue Y, Zhang J, Frangi A, Yang J. Precision TAVR quantification- AI-accelerated TAVR planning reduces assessment time by 80% in bicuspid aortic stenosis. Eur Heart J Imaging Methods Pract. 2025 Dec 5;3(4):qyaf153. doi: 10.1093/ehjimp/qyaf153. eCollection 2025 Oct.
- Individual participant dataSharing planned: No
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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.
yongjian wu, doctor study chair
Fuwai Hospital, National Center for Cardiovascular Diseases，Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Valvular Heart Disease, run by Yongjian Wu at 1 site 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 9 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: status not confirmed, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact haiyan xu, doctor (+86 13681012249, xuhaiyan@fuwaihospital.org), 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: Time Frame: 2years). 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 NCT05044338, which also lists 3 linked publications.
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 16 Sep 2021.