Heart Valve DiseasesNCT07068633
Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice
An observational study of Heart Valve Diseases and Aortic Valve Stenosis, run by Yonsei University at 2 sites in South Korea.
Trial summary
Valvular heart disease (VHD) is a growing public health concern globally, with increasing disease burden and rising interest in advanced treatment strategies such as transcatheter interventions. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Heart Valve Diseases, Aortic Valve Stenosis, Aortic Valve Insufficiency
- How many people
- 30,000 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 22 Sep 2025to 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This retrospective study includes adult patients (≥18 years) diagnosed with moderate or severe valvular heart disease (VHD) between January 1, 2010, and December 31, 2020, at tertiary hospitals in South Korea. Eligible patients must have undergone at least two transthoracic echocardiograms. Patients will be identified consecutively from echocardiographic and electronic medical record (EMR) databases. Exclusion criteria include congenital heart disease, prior valve surgery at baseline, and incomplete imaging or clinical data. Patients will be classified by valve type (aortic stenosis, aortic regurgitation, mitral regurgitation, tricuspid regurgitation), severity (moderate vs. severe), and etiology (degenerative, rheumatic, endocarditis, etc.). Demographic information such as age, sex, and comorbidities will be collected. The estimated sample size is expected to exceed 10,000 patients based on the number of participating centers and the 10-year study period.
Who may be able to join
- Period: 2010.1.1~2020.12.31
- Age > 18 years
- Moderate or severe native VHD (AS, AR, MR and TR)
- Perform echocardiography more than twice
Who cannot join
- Poor image of echocardiography
- Follow up loss
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea2 sites, 2 recruiting
- Recruiting
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, Seoul, 03722
Geu-Ru Hong, MD, PhD, 82-2-2228-8443, GRHONG@yuhs.ac
- Recruiting
Yonsei University College of Medicine
Seoul
Geu-Ru Hong, 82-2-2228-8443, GRHONG@yuhs.ac
About this study
Valvular heart disease (VHD) is a growing public health concern globally, with increasing disease burden and rising interest in advanced treatment strategies such as transcatheter interventions. However, there remains a significant lack of real-world data regarding echocardiography practices, disease prevalence and progression, referral patterns, and treatment pathways. Addressing these gaps is critical for improving patient care and informing clinical decision-making.
South Korea provides a unique opportunity to conduct a nationwide retrospective echocardiographic study due to its advanced healthcare infrastructure, high patient volume, and strong tradition in clinical research. The current study aims to evaluate the real-world burden and clinical journey of patients with moderate or severe valvular disease over a 10-year period, based on echocardiographic and electronic medical record (EMR) data collected from multiple tertiary centers across the country.
Read the detailed description
This is a multicenter, retrospective observational study conducted using data from January 1, 2010 to December 31, 2020. The study will include adult patients (≥18 years old) who underwent at least two transthoracic echocardiograms during the study period. Eligible patients will be identified consecutively from each participating institution's echocardiographic and EMR databases. Patients with moderate or severe valvular heart disease (VHD), as defined by guideline-based echocardiographic criteria, will be included in the final analysis.
Patients with congenital heart disease, previous valve surgery at baseline, or incomplete clinical or imaging data will be excluded. The data collected will include demographics, comorbidities, echocardiographic parameters, and clinical outcomes such as mortality and treatment interventions. Particular attention will be paid to disease severity at baseline, rate of progression (from mild to severe), and time to treatment. Treatment patterns, including referral to surgery or transcatheter valve interventions (e.g., TAVI), will also be explored.
Sampling will follow a non-probability, consecutive patient sampling approach, as patients are retrospectively identified based on predefined eligibility criteria. The final sample size is estimated based on precedent data from a previous Korean VHD study that included ~4,000 patients over a 2-month period across 45 centers. Given the 10-year study duration and the number of participating institutions, a larger and more comprehensive sample is expected in this study.
- Conditions
- Heart Valve Diseases, Aortic Valve Stenosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency, Mitral Valve Prolapse, Tricuspid Valve Insufficiency
- Medical subject headings
- Heart Valve Diseases, Aortic Valve Stenosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency, Mitral Valve Prolapse, Tricuspid Valve Insufficiency, Rheumatic Heart Disease, Aortic 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 |
|---|---|---|
| Aortic petients | Primary focus is aortic stenosis patients; secondary focus is aortic regurgitation. | |
| Mitral Patients | Primary focus is Degenerative Mitral Regurgitation patients; secondary focus is Functional Mitral Regurgitation. | |
| Tricuspid Patients | Primary focus is Tircuspid Regurgitation patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Moderate and Severe Valvular Heart Disease (VHD)
Evaluate the prevalence of moderate and severe VHD (including AS, AR, MR, and TR) based on echocardiographic findings and diagnostic records during the study period.
Measured: January 1, 2010 - December 31, 2020
Etiological Classification of Aortic Stenosis (AS)
Classify AS cases retrospectively into degenerative, bicuspid, rheumatic, infective endocarditis, or aortopathy based on clinical records and imaging data.
Measured: January 1, 2010 - December 31, 2020
Etiological Classification of Aortic Regurgitation (AR)
Categorize AR patients according to underlying causes: degenerative, bicuspid, rheumatic, infective endocarditis, or aortopathy.
Measured: January 1, 2010 - December 31, 2020
Etiological Classification of Mitral Regurgitation (MR)
Retrospectively classify MR into primary MR (degenerative, mitral valve prolapse, rheumatic, endocarditis) and secondary MR (ventricular functional MR, atrial functional MR).
Measured: January 1, 2010 - December 31, 2020
Classification of Tricuspid Regurgitation (TR)
Classify TR cases into primary and secondary based on echocardiographic findings and clinical context.
Measured: January 1, 2010 - December 31, 2020
Disease Progression and Treatment Pathway
Analyze the time course of VHD progression from mild to moderate to severe and track the time to intervention (surgical or transcatheter) using retrospective patient records.
Measured: January 1, 2010 - December 31, 2020
Secondary outcomes (2)
All-Cause and Cardiovascular Mortality
Assess the incidence of all-cause mortality and cardiovascular-specific mortality among patients with valvular heart disease, using hospital records and national death registry data (if available).
Measured: From initial diagnosis to date of death or last follow-up (within 2010-2020)
Treatment Pathway by Disease Severity
Evaluate how the treatment approach (medical management, surgical valve repair/replacement, or transcatheter intervention) varies according to disease severity (mild, moderate, severe) across different types of VHD.
Measured: From initial diagnosis to date of death or last follow-up (within 2010-2020)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start22 Sep 2025
- Primary completion31 Dec 2027 (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.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068633
- Sponsor's protocol ID
- 4-2024-1451
- Status last verified
- Oct 2026
- First submitted
- 7 Jul 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice
- ClinicalTrials.gov ID
- NCT07068633
- Acronym / sponsor ID
- 4-2024-1451
- Conditions
- Heart Valve Diseases, Aortic Valve Stenosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency, Mitral Valve Prolapse, Tricuspid Valve Insufficiency
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Jul 2025 (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.
Valvular heart disease (VHD) is a growing public health concern globally, with increasing disease burden and rising interest in advanced treatment strategies such as transcatheter interventions. However, there remains a significant lack of real-world data regarding echocardiography practices, disease prevalence and progression, referral patterns, and treatment pathways. Addressing these gaps is critical for improving patient care and informing clinical decision-making.
South Korea provides a unique opportunity to conduct a nationwide retrospective echocardiographic study due to its advanced healthcare infrastructure, high patient volume, and strong tradition in clinical research. The current study aims to evaluate the real-world burden and clinical journey of patients with moderate or severe valvular disease over a 10-year period, based on echocardiographic and electronic medical record (EMR) data collected from multiple tertiary centers across the country.
Detailed description
This is a multicenter, retrospective observational study conducted using data from January 1, 2010 to December 31, 2020. The study will include adult patients (≥18 years old) who underwent at least two transthoracic echocardiograms during the study period. Eligible patients will be identified consecutively from each participating institution's echocardiographic and EMR databases. Patients with moderate or severe valvular heart disease (VHD), as defined by guideline-based echocardiographic criteria, will be included in the final analysis.
Patients with congenital heart disease, previous valve surgery at baseline, or incomplete clinical or imaging data will be excluded. The data collected will include demographics, comorbidities, echocardiographic parameters, and clinical outcomes such as mortality and treatment interventions. Particular attention will be paid to disease severity at baseline, rate of progression (from mild to severe), and time to treatment. Treatment patterns, including referral to surgery or transcatheter valve interventions (e.g., TAVI), will also be explored.
Sampling will follow a non-probability, consecutive patient sampling approach, as patients are retrospectively identified based on predefined eligibility criteria. The final sample size is estimated based on precedent data from a previous Korean VHD study that included ~4,000 patients over a 2-month period across 45 centers. Given the 10-year study duration and the number of participating institutions, a larger and more comprehensive sample is expected in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aortic petients | – | –Primary focus is aortic stenosis patients; secondary focus is aortic regurgitation. |
| Mitral Patients | – | –Primary focus is Degenerative Mitral Regurgitation patients; secondary focus is Functional Mitral Regurgitation. |
| Tricuspid Patients | – | –Primary focus is Tircuspid Regurgitation patients |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective study includes adult patients (≥18 years) diagnosed with moderate or severe valvular heart disease (VHD) between January 1, 2010, and December 31, 2020, at tertiary hospitals in South Korea. Eligible patients must have undergone at least two transthoracic echocardiograms. Patients will be identified consecutively from echocardiographic and electronic medical record (EMR) databases. Exclusion criteria include congenital heart disease, prior valve surgery at baseline, and incomplete imaging or clinical data. Patients will be classified by valve type (aortic stenosis, aortic regurgitation, mitral regurgitation, tricuspid regurgitation), severity (moderate vs. severe), and etiology (degenerative, rheumatic, endocarditis, etc.). Demographic information such as age, sex, and comorbidities will be collected. The estimated sample size is expected to exceed 10,000 patients based on the number of participating centers and the 10-year study period.
Key inclusion criteria (4 listed)
- Period: 2010.1.1~2020.12.31
- Age > 18 years
- Moderate or severe native VHD (AS, AR, MR and TR)
- Perform echocardiography more than twice
Key exclusion criteria (2 listed)
- Poor image of echocardiography
- Follow up loss
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
Prevalence of Moderate and Severe Valvular Heart Disease (VHD)
Time frame: January 1, 2010 - December 31, 2020
Evaluate the prevalence of moderate and severe VHD (including AS, AR, MR, and TR) based on echocardiographic findings and diagnostic records during the study period.
Etiological Classification of Aortic Stenosis (AS)
Time frame: January 1, 2010 - December 31, 2020
Classify AS cases retrospectively into degenerative, bicuspid, rheumatic, infective endocarditis, or aortopathy based on clinical records and imaging data.
Etiological Classification of Aortic Regurgitation (AR)
Time frame: January 1, 2010 - December 31, 2020
Categorize AR patients according to underlying causes: degenerative, bicuspid, rheumatic, infective endocarditis, or aortopathy.
Etiological Classification of Mitral Regurgitation (MR)
Time frame: January 1, 2010 - December 31, 2020
Retrospectively classify MR into primary MR (degenerative, mitral valve prolapse, rheumatic, endocarditis) and secondary MR (ventricular functional MR, atrial functional MR).
Classification of Tricuspid Regurgitation (TR)
Time frame: January 1, 2010 - December 31, 2020
Classify TR cases into primary and secondary based on echocardiographic findings and clinical context.
Disease Progression and Treatment Pathway
Time frame: January 1, 2010 - December 31, 2020
Analyze the time course of VHD progression from mild to moderate to severe and track the time to intervention (surgical or transcatheter) using retrospective patient records.
2 secondary outcomes
All-Cause and Cardiovascular Mortality
Time frame: From initial diagnosis to date of death or last follow-up (within 2010-2020)
Treatment Pathway by Disease Severity
Time frame: From initial diagnosis to date of death or last follow-up (within 2010-2020)
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 30 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, South Korea
2 sites 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 Aortic Valve Stenosis, run by Yonsei University at 2 sites in South Korea.
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 4 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: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Moderate and Severe Valvular Heart Disease (VHD) (time frame: January 1, 2010 - December 31, 2020). The study lists 6 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 30 Oct 2026.