Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, 03722, South Korea
NCT Number: NCT07068633
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.
Trial opening soon.
Get Notified19 year and older
All sexes
Observational
Seoul, 03722, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: January 1, 2010 - December 31, 2020
Categorize AR patients according to underlying causes: degenerative, bicuspid, rheumatic, infective endocarditis, or aortopathy.
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).
Time frame: January 1, 2010 - December 31, 2020
Classify TR cases into primary and secondary based on echocardiographic findings and clinical context.
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.
Time frame: From initial diagnosis to date of death or last follow-up (within 2010-2020)
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).
Time frame: From initial diagnosis to date of death or last follow-up (within 2010-2020)
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.
Yonsei University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06235385
Aortic Valve Disease, Aortic Valve Insufficiency
Paris, Île-de-France Region, France
View Trial DetailsNCT05714293
Aortic Regurgitation, Aortic Stenosis, Severe
Roma, Italy
View Trial DetailsNCT04190602
Cardiovascular Diseases, Heart Diseases
Bonn, Germany
View Trial DetailsNCT05536310
Aortic Stenosis, Severe, Aortic Valve Disease
Bad Oeynhausen, Germany
View Trial Details