Heart Valve DiseasesNCT07816146
China Elderly Valve Disease Study III (China-DVD3 Study)
An observational study of Heart Valve Diseases and Moderate to Severe Valve Disease in the Elderly, run by Yongjian Wu, MD, PhD at 1 site in China.
Trial summary
This study aims to conduct a second round of multicenter, prospective registry research targeting elderly patients with valvular heart disease, to understand the current status of interventions for patients with valvular heart disease. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Heart Valve Diseases, Moderate to Severe Valve Disease in the Elderly
- How many people
- 6,612 participants
- Where
- 1 siteChina
- Study dates
- 7 Sep 2026to 31 Dec 2027
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This project is scheduled to be implemented from September to December 2026. It will consecutively enroll hospitalized patients with moderate and severe valvular heart disease across the original 69 national research centers of China-DVD, with the research protocol and definitions fully consistent with those in 2016.
Who may be able to join
- Hospitalized patients over 60 years old meet one of the following conditions.
- 1、 moderate or above valvular heart disease as defined by echocardiography: One of the following criteria
- (1)Mitral stenosis : Valve area ≤1.5 cm², or mean pressure gradient ≥10 mmHg.
- (2)Mitral regurgitation : Moderate and above regurgitation, or regurgitant jet width ≥ 3 mm, or regurgitant volume per beat ≥ 30 ml, or regurgitant jet area/left atrial area > 20%; or effective regurgitant orifice area (EROA) ≥ 20 mm²
- (3)Aortic stenosis : Moderate and above, mean pressure gradient ≥ 20 mmHg, or peak jet velocity ≥ 3 m/s, or valve area ≤ 1.5 cm²
- (4)Aortic regurgitation : Moderate and above regurgitation, or regurgitant jet width ≥ 3 mm, or regurgitant volume per beat ≥ 30 ml, or regurgitant fraction ≥ 30%, or jet width occupying ≥ 25% of the left ventricular outflow tract, or effective regurgitant orifice area (EROA) ≥ 10 mm²
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- (5)Tricuspid stenosis : Moderate and above
- (6)Tricuspid regurgitation : Moderate and above regurgitation, or jet area ≥ 5 cm²
- (7)Pulmonary stenosis : Moderate and above
- (8）Pulmonary regurgitation : Moderate and above regurgitation 2 、Previous history of cardiac valve surgery or interventional therapy (dilation, valvuloplasty, valve replacement) 3、Diagnosed with infective endocarditis
Who cannot join
- Patients unwilling to accept registration and follow-up;
- Patients with mental illness who cannot cooperate with information collection and follow-up Patients have been enrolled in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fuwai Hospital, National Center for Cardiovascular Diseases，Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100037
Yongjian Wu, PhD, +86 13701387189, fuwaihospital@hotmail.com
About this study
Official title: Third National Multicenter Registered Cohort Study of Hospitalized Elderly Patients With Valvular Heart Disease Based on the China-DVD Network
This study aims to conduct a second round of multicenter, prospective registry research targeting elderly patients with valvular heart disease, to understand the current status of interventions for patients with valvular heart disease. To systematically evaluate the distribution of types, clinical characteristics, interventions, and complications of elderly valvular heart disease, and to compare and analyze these with the China-DVD data from 2016, thereby revealing its evolutionary trends. By comprehensively considering various clinical characteristics such as different types of valvular lesions, treatment modalities, patient cardiac function, comorbidities, and blood test indicators, as well as multidimensional factors including psychological and lifestyle aspects, to deeply identify the key determinants influencing the treatment of elderly valvular heart disease patients in China, and thus optimize and improve their individualized comprehensive management pathways.
- Keywords
- Heart Valve Diseases, Valvular Heart Diseases, Senile valve disease
- 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.
| Study group | Role | What they receive |
|---|---|---|
| China elderly Valve Disease Study III (China-DVD3 study) | This study aims to conduct a second round of multicenter, prospective registry research targeting elderly patients with valvular heart disease, to understand the current status of interventions for patients with valvular heart disease. To systematically evaluate the distribution of types, clinical characteristics, interventions, and complications of elderly valvular heart disease, and to compare and analyze these with the China-DVD data from 2016, thereby revealing its evolutionary trends. By comprehensively considering various clinical characteristics such as different types of valvular lesions, treatment modalities, patient cardiac function, comorbidities, and blood test indicators, as well as multidimensional factors including psychological and lifestyle aspects, to deeply identify the key determinants influencing the treatment of elderly valvular heart disease patients in China, and thus optimize and improve their individualized comprehensive management pathways. |
What is being measured
The primary outcome is the main question the study is designed to answer.
First valve intervention during this hospitalization
Underwent their first internal medicine intervention or surgical procedure during hospitalization for valvular heart disease in this study
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (1)
1、Repeat valve intervention 2、Cardiovascular adverse events
1 、Repeat valve intervention : After the first valve intervention, the patient receives another valve surgical or interventional procedure due to valvular-related causes.
2、Cardiovascular adverse events : Any new-onset or recurrent cardiovascular disease, rehospitalization for cardiovascular reasons, and cardiac death, etc.
Measured: From enrollment to the 12-month follow-up endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start7 Sep 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Valve DiseasesStudies 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
- 6,612 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yongjian Wu, MD, PhD
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Yongjian Wu, MD, PhD, 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
- NCT07816146
- Sponsor's protocol ID
- 2025-ZX223/2026-GPS-GG-24
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Third National Multicenter Registered Cohort Study of Hospitalized Elderly Patients With Valvular Heart Disease Based on the China-DVD Network
- ClinicalTrials.gov ID
- NCT07816146
- Acronym / sponsor ID
- 2025-ZX223/2026-GPS-GG-24
- Keywords
- Heart Valve Diseases, Valvular Heart Diseases, Senile valve disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 6,612 participants (estimated)
- Lead sponsor
- Yongjian Wu, MD, PhDOther government
- Study start
- 7 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Sep 2026 (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 aims to conduct a second round of multicenter, prospective registry research targeting elderly patients with valvular heart disease, to understand the current status of interventions for patients with valvular heart disease. To systematically evaluate the distribution of types, clinical characteristics, interventions, and complications of elderly valvular heart disease, and to compare and analyze these with the China-DVD data from 2016, thereby revealing its evolutionary trends. By comprehensively considering various clinical characteristics such as different types of valvular lesions, treatment modalities, patient cardiac function, comorbidities, and blood test indicators, as well as multidimensional factors including psychological and lifestyle aspects, to deeply identify the key determinants influencing the treatment of elderly valvular heart disease patients in China, and thus optimize and improve their individualized comprehensive management pathways.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| China elderly Valve Disease Study III (China-DVD3 study) | – | –This study aims to conduct a second round of multicenter, prospective registry research targeting elderly patients with valvular heart disease, to understand the current status of interventions for patients with valvular heart disease. To systematically evaluate the distribution of types, clinical characteristics, interventions, and complications of elderly valvular heart disease, and to compare and analyze these with the China-DVD data from 2016, thereby revealing its evolutionary trends. By comprehensively considering various clinical characteristics such as different types of valvular lesions, treatment modalities, patient cardiac function, comorbidities, and blood test indicators, as well as multidimensional factors including psychological and lifestyle aspects, to deeply identify the key determinants influencing the treatment of elderly valvular heart disease patients in China, and thus optimize and improve their individualized comprehensive management pathways. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This project is scheduled to be implemented from September to December 2026. It will consecutively enroll hospitalized patients with moderate and severe valvular heart disease across the original 69 national research centers of China-DVD, with the research protocol and definitions fully consistent with those in 2016.
Key inclusion criteria (10 listed)
- Hospitalized patients over 60 years old meet one of the following conditions.
- 1、 moderate or above valvular heart disease as defined by echocardiography: One of the following criteria
- (1)Mitral stenosis : Valve area ≤1.5 cm², or mean pressure gradient ≥10 mmHg.
- (2)Mitral regurgitation : Moderate and above regurgitation, or regurgitant jet width ≥ 3 mm, or regurgitant volume per beat ≥ 30 ml, or regurgitant jet area/left atrial area > 20%; or effective regurgitant orifice area (EROA) ≥ 20 mm²
- (3)Aortic stenosis : Moderate and above, mean pressure gradient ≥ 20 mmHg, or peak jet velocity ≥ 3 m/s, or valve area ≤ 1.5 cm²
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 Patients have been enrolled in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
First valve intervention during this hospitalization
Time frame: From enrollment to the end of treatment at 12 weeks
Underwent their first internal medicine intervention or surgical procedure during hospitalization for valvular heart disease in this study
1 secondary outcome
1、Repeat valve intervention 2、Cardiovascular adverse events
Time frame: From enrollment to the 12-month follow-up endpoint
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 11 Sep 2026.
- 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.
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 Heart Valve Diseases and Moderate to Severe Valve Disease in the Elderly, run by Yongjian Wu, MD, PhD 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 10 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 11 Sep 2026. 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?
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 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?
First valve intervention during this hospitalization (time frame: From enrollment to the end of treatment at 12 weeks). 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 11 Sep 2026.