Clinical Trials in China / NCT07918937
Starting soon
Observational
Multi-center Study of Three-Dimensional Transesophageal Echocardiography in Patients With Secondary Mitral Regurgitation
NCT07918937 · tracked via the Priya Life Science China tracker
Condition(s) studied
Mitral Valve Insufficiency
Investigational drug(s) / intervention(s)
Transthoracic and Three-Dimensional Transesophageal Echocardiography
Transthoracic and Three-Dimensional Transesophageal Echocardiography: Participants will undergo transthoracic and three-dimensional transesophageal echocardiography using standardized image acquisition procedures. Images will be analyzed centrally to assess mitral valve morphology, regurgitation severity, and cardiac function. Transesophageal examinations will be performed for clinical indications, without additional examinations solely for research participation.
Study summary
Three-dimensional transesophageal echocardiography (3D-TEE) enables detailed assessment of mitral valve anatomy, annular geometry, and regurgitation. This prospective multicenter observational study will evaluate atrial secondary mitral regurgitation (A-SMR) using 3D-TEE combined with transthoracic echocardiography. The study aims to characterize regurgitation severity and associated factors and compare mitral valve structure and left ventricular function between patients and controls. It will also investigate echocardiographic predictors of clinical outcomes during follow-up.
Eligibility
Inclusion Criteria:
Atrial Secondary Mitral Regurgitation Group:
1. Age 18 years or older.
2. At least mild atrial secondary mitral regurgitation, meeting all of the following criteria:
* Structurally normal mitral valve without primary mitral valve disease.
* Left ventricular ejection fraction ≥50%, without regional wall motion abnormalities or mitral leaflet tethering.
* Normal or mildly enlarged left ventricle, meeting either of the following sex-specific criteria:
* Left ventricular end-diastolic diameter \<56 mm in women or \<63 mm in men.
* Left ventricular end-diastolic volume index \<71 mL/m² in women or \<79 mL/m² in men.
* Mitral annular dilatation, defined as an anteroposterior diameter \>35 mm, together with left atrial enlargement meeting either of the following criteria:
* Left atrial volume index \>34 mL/m².
* Left atrial anteroposterior diameter \>37 mm in women or \>39 mm in men.
3. Undergoing both transthoracic and transesophageal echocardiography, with standardized images retained.
Control Group:
1. Age 18 years or older.
2. Undergoing transesophageal echocardiography for clinical indications, such as suspected patent foramen ovale or infective endocarditis.
3. Transthoracic echocardiography showing no significant abnormalities in cardiac structure or function, with less than mild regurgitation of all cardiac valves.
All participants must meet the inclusion criteria for their respective group and provide written informed consent.
Exclusion Criteria:
The following exclusion criteria apply to both groups:
1. Primary mitral regurgitation caused by organic mitral valve disease, including degenerative changes, rheumatic involvement, congenital mitral valve abnormalities, or vegetations.
2. Moderate or greater aortic valve disease.
3. Previous cardiac valve surgery or catheter-based valve intervention.
4. Congenital heart disease.
5. Inadequate three-dimensional transesophageal echocardiographic image quality that precludes reliable assessment of mitral valve structure and motion.
6. Contraindications to, or inability to tolerate, transesophageal echocardiography.
7. Refusal to provide written informed consent.
Primary outcome measure(s)
- Number of Participants With Heart Failure Rehospitalization — From enrollment through 12 months
Number of participants rehospitalized for heart failure during follow-up. Events will be identified through outpatient visits or telephone interviews and checked against medical records. - Number of Participants With Cardiovascular Death — From enrollment through 12 months
Number of participants who die from cardiovascular causes during follow-up. Outcome information will be collected through follow-up and checked against medical records. - Number of Participants Undergoing Mitral Valve Intervention — From enrollment through 12 months
Number of participants undergoing mitral valve intervention during follow-up, including interventional or surgical treatment. Events will be identified through follow-up and checked against medical records.
Trial sites (93)
| Facility | City | Region | Status |
|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | |
| Chongqing Emergency Medical Center | Chongqing | Chongqing Municipality | |
| Southwest Hospital of Army Medical University | Chongqing | Chongqing Municipality | |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | |
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | |
| Xinqiao Hospital of Army Medical University | Chongqing | Chongqing Municipality | |
| Fujian Medical University Union Hospital (Qishan Campus) | Fuzhou | Fujian | |
| Zhangzhou Hospital of Fujian Province | Zhangzhou | Fujian | |
| The First Hospital of Lanzhou University | Lanzhou | Gansu | |
| The First People's Hospital of Tianshui | Tianshui | Gansu | |
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | |
| Nanfang Hospital of Southern Medical University | Guangzhou | Guangdong | |
| The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | |
| Shantou Central Hospital | Shantou | Guangdong | |
| Fuwai Hospital, Chinese Academy of Medical Sciences Shenzhen Hospital | Shenzhen | Guangdong | |
| The First Affiliated Hospital of Guangxi University of Science and Technology | Liuzhou | Guangxi | |
| The First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | |
| The First People's Hospital of Yulin | Yulin | Guangxi | |
| Affiliated Hospital of Guizhou Medical University | Guiyang | Guizhou | |
| Guizhou Provincial People's Hospital | Guiyang | Guizhou | |
| The First Hospital of Hebei Medical University | Shijiazhuang | Hebei | |
| The Second Hospital of Hebei Medical University (Luquan Campus) | Shijiazhuang | Hebei | |
| The First Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | |
| The Second Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | |
| The Second Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | |
| The Second Hospital of Harbin | Harbin | Heilongjiang | |
| Fuwai Central China Cardiovascular Hospital | Zhengzhou | Henan | |
| Minda Hospital of Hubei Minzu University | Enshi | Hubei | |
| Huangshi Central Hospital | Huangshi | Hubei | |
| Jingmen Central Hospital | Jingmen | Hubei | |
| Jingzhou Central Hospital | Jingzhou | Hubei | |
| Sinopharm Dongfeng General Hospital Affiliated to Hubei University of Medicine | Shiyan | Hubei | |
| Taihe Hospital of Shiyan | Shiyan | Hubei | |
| Renmin Hospital of Wuhan University | Wuhan | Hubei | |
| The Sixth Hospital of Wuhan Affiliated to Jianghan University | Wuhan | Hubei | |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | |
| Wuhan Asia Heart Hospital | Wuhan | Hubei | |
| Wuhan Central Hospital | Wuhan | Hubei | |
| Wuhan First Hospital | Wuhan | Hubei |
+ 53 more sites — see the full list on the official registry below.
More First Hospital of China Medical University trials in China
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07918937 on ClinicalTrials.gov ↗ ← All trials in China