Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2026-01-01 @ 3:35 AM
Study NCT ID:
NCT07068633
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-16
First Post:
2025-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice
Sponsor:
Yonsei University
Organization:
Study Overview
Official Title:
Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: