Multi-center Study of Three-Dimensional Transesophageal Echocardiography in Patients With Secondary Mitral Regurgitation (SMR-3DTEE)

October 31, 2026 updated by: Chunyan Ma, First Hospital of China Medical University

A Secondary Mitral Regurgitation Assessment Using Three-dimensional Transesophageal Echocardiography: A Multicenter Clinical Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Secondary mitral regurgitation (SMR) develops when changes in left atrial or ventricular geometry and function impair mitral leaflet coaptation without primary structural valve disease. Mitral annular dilatation and altered leaflet geometry contribute to regurgitation.

Conventional transthoracic echocardiography (TTE) is used to assess regurgitation severity and cardiac function, but may incompletely characterize three-dimensional mitral valve geometry. Three-dimensional transesophageal echocardiography (3D-TEE) provides high-resolution visualization of the mitral apparatus and supports assessment of regurgitation and annular remodeling. Combining 3D-TEE with TTE permits evaluation of valve anatomy alongside cardiac structure and function.

This prospective observational study will be conducted across multiple hospitals in China. It plans to enroll 2,400 adults, including 1,600 patients with at least mild atrial SMR and 800 controls. Control participants will have a clinical indication for TEE and no substantial structural or functional cardiac abnormalities on TTE.

Participating centers will follow standardized acquisition procedures for TTE and 3D-TEE. TEE examinations will be performed for clinical indications, without additional TEE procedures solely for research participation. Images will be transferred to the First Hospital of China Medical University for centralized analysis using the Ultrasound Workspace workstation. Mitral valve morphology, regurgitation, and conventional and three-dimensional echocardiographic parameters will be assessed using standardized measurements.

Patients and controls will be compared to characterize differences in mitral valve structure and left ventricular function. Clinical follow-up will be conducted every three months through outpatient visits or telephone interviews, supplemented by medical records. Analyses will investigate associations between echocardiographic findings and subsequent clinical outcomes, including atrial fibrillation recurrence, heart failure rehospitalization, cardiovascular death, and mitral valve intervention.

Study Type

Observational

Enrollment (Estimated)

2400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • The First Affiliated Hospital of Anhui Medical University
        • Principal Investigator:
          • Xuegong Shi
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China
        • The First Affiliated Hospital of Chongqing Medical University
        • Principal Investigator:
          • Qian Dong
      • Chongqing, Chongqing Municipality, China
        • The Second Affiliated Hospital of Chongqing Medical University
        • Principal Investigator:
          • Jianli Ren
      • Chongqing, Chongqing Municipality, China
        • Chongqing Emergency Medical Center
        • Principal Investigator:
          • Yan Du
      • Chongqing, Chongqing Municipality, China
        • Southwest Hospital of Army Medical University
        • Principal Investigator:
          • Yanli Guo
      • Chongqing, Chongqing Municipality, China
        • Xinqiao Hospital of Army Medical University
        • Principal Investigator:
          • Hongmei Xia
    • Fujian
      • Fuzhou, Fujian, China
        • Fujian Medical University Union Hospital (Qishan Campus)
        • Principal Investigator:
          • Xudong Sun
      • Zhangzhou, Fujian, China
        • Zhangzhou Hospital of Fujian Province
        • Principal Investigator:
          • Shuping Yang
    • Gansu
      • Lanzhou, Gansu, China
        • The First Hospital of Lanzhou University
        • Principal Investigator:
          • Lu Zhang
      • Tianshui, Gansu, China
        • The First People's Hospital of Tianshui
        • Principal Investigator:
          • Maolin Wu
    • Guangdong
      • Guangzhou, Guangdong, China
        • Guangdong Provincial People's Hospital
        • Principal Investigator:
          • Hongwen Fei
      • Guangzhou, Guangdong, China
        • Nanfang Hospital of Southern Medical University
        • Principal Investigator:
          • Juefei Wu
      • Guangzhou, Guangdong, China
        • The First Affiliated Hospital of Sun Yat-sen University
        • Principal Investigator:
          • Fengjuan Yao
      • Shantou, Guangdong, China
        • Shantou Central Hospital
        • Principal Investigator:
          • Liangyu Wang
      • Shenzhen, Guangdong, China
        • Fuwai Hospital, Chinese Academy of Medical Sciences Shenzhen Hospital
        • Principal Investigator:
          • Yong Jiang
    • Guangxi
      • Liuzhou, Guangxi, China
        • The First Affiliated Hospital of Guangxi University of Science and Technology
        • Principal Investigator:
          • Gaoxing Wang
      • Nanning, Guangxi, China
        • The First Affiliated Hospital of Guangxi Medical University
        • Principal Investigator:
          • Ji Wu
      • Yulin, Guangxi, China
        • The First People's Hospital of Yulin
        • Principal Investigator:
          • Yuxuan Luo
    • Guizhou
      • Guiyang, Guizhou, China
        • Guizhou Provincial People's Hospital
        • Principal Investigator:
          • Yaning Chen
      • Guiyang, Guizhou, China
        • Affiliated Hospital of Guizhou Medical University
        • Principal Investigator:
          • Shaomei Yu
    • Hebei
      • Shijiazhuang, Hebei, China
        • The First Hospital of Hebei Medical University
        • Principal Investigator:
          • Wugang Wang
      • Shijiazhuang, Hebei, China
        • The Second Hospital of Hebei Medical University (Luquan Campus)
        • Principal Investigator:
          • Yajing Miao
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • The Second Affiliated Hospital of Harbin Medical University
        • Principal Investigator:
          • Hairu Li
        • Principal Investigator:
          • Sining Hu
      • Harbin, Heilongjiang, China
        • The First Affiliated Hospital of Harbin Medical University
        • Principal Investigator:
          • Danyang Yu
      • Harbin, Heilongjiang, China
        • The Second Hospital of Harbin
        • Principal Investigator:
          • Fangfang Zhu
    • Henan
      • Zhengzhou, Henan, China
        • Fuwai Central China Cardiovascular Hospital
        • Principal Investigator:
          • Juan Cong
    • Hubei
      • Enshi, Hubei, China
        • Minda Hospital of Hubei Minzu University
        • Principal Investigator:
          • Gongquan Chen
      • Huangshi, Hubei, China
        • Huangshi Central Hospital
        • Principal Investigator:
          • Zhian Hu
      • Jingmen, Hubei, China
        • Jingmen Central Hospital
        • Principal Investigator:
          • Xueying Chen
      • Jingzhou, Hubei, China
        • Jingzhou Central Hospital
        • Principal Investigator:
          • Qiang Zhang
      • Shiyan, Hubei, China
        • Taihe Hospital of Shiyan
        • Principal Investigator:
          • Dingfang Yan
      • Shiyan, Hubei, China
        • Sinopharm Dongfeng General Hospital Affiliated to Hubei University of Medicine
        • Principal Investigator:
          • Haiyan Wu
      • Wuhan, Hubei, China
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Principal Investigator:
          • Yani Liu
      • Wuhan, Hubei, China
        • Wuhan Asia Heart Hospital
        • Principal Investigator:
          • Xiaojing Ma
      • Wuhan, Hubei, China
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Principal Investigator:
          • Mingxing Xie
      • Wuhan, Hubei, China
        • Zhongnan Hospital of Wuhan University
        • Principal Investigator:
          • Bin Wang
      • Wuhan, Hubei, China
        • Wuhan Central Hospital
        • Principal Investigator:
          • Fengxia Jiang
      • Wuhan, Hubei, China
        • Renmin Hospital of Wuhan University
        • Principal Investigator:
          • Qing Zhou
      • Wuhan, Hubei, China
        • Wuhan First Hospital
        • Principal Investigator:
          • Jia Ge
      • Wuhan, Hubei, China
        • The Sixth Hospital of Wuhan Affiliated to Jianghan University
        • Principal Investigator:
          • Aihua Liu
      • Yichang, Hubei, China
        • Yichang Central People's Hospital
        • Principal Investigator:
          • Chang Zhou
    • Hunan
      • Changsha, Hunan, China
        • The Second Xiangya Hospital of Central South University
        • Principal Investigator:
          • Qin Wu
      • Hengyang, Hunan, China
        • The First Affiliated Hospital of University of South China
        • Principal Investigator:
          • Jia Zhou
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Jiangsu Province Hospital of Chinese Medicine
        • Principal Investigator:
          • Anxia He
      • Nanjing, Jiangsu, China
        • Jiangsu Province Hospital (The First Affiliated Hospital of Nanjing Medical University)
        • Principal Investigator:
          • Yonghong Yong
      • Wuxi, Jiangsu, China
        • Wuxi Hospital of Traditional Chinese Medicine
        • Principal Investigator:
          • Lingjun Li
      • Wuxi, Jiangsu, China
        • Wuxi People's Hospital (Wuxi People's Hospital Affiliated to Nanjing Medical University)
        • Principal Investigator:
          • Jun Tan
    • Jiangxi
      • Nanchang, Jiangxi, China
        • The Second Affiliated Hospital of Nanchang University
        • Principal Investigator:
          • Chunquan Zhang
      • Nanchang, Jiangxi, China
        • The First Affiliated Hospital of Nanchang University
        • Principal Investigator:
          • Xinchun Yuan
    • Jilin
      • Changchun, Jilin, China
        • China-Japan Union Hospital of Jilin University
        • Principal Investigator:
          • Hui Wang
      • Changchun, Jilin, China
        • First Hospital of Jilin University
        • Principal Investigator:
          • Hui Xu
      • Changchun, Jilin, China
        • Second Hospital of Jilin University
        • Principal Investigator:
          • Dongmei Lyu
    • Liaoning
      • Chaoyang, Liaoning, China
        • Chaoyang Central Hospital
        • Principal Investigator:
          • Hong Zhou
      • Dalian, Liaoning, China
        • Dalian Central Hospital Affiliated to Dalian University of Technology
        • Principal Investigator:
          • Yu Dong
      • Jinzhou, Liaoning, China
        • The First Affiliated Hospital of Jinzhou Medical University
        • Principal Investigator:
          • Lili Ge
      • Liaoyang, Liaoning, China
        • Liaoyang Central Hospital
        • Principal Investigator:
          • Ying Guo
      • Shenyang, Liaoning, China, 110001
        • First Hospital of China Medical University
        • Contact:
        • Principal Investigator:
          • Chunyan Ma, Ph.D.
      • Shenyang, Liaoning, China
        • Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
        • Principal Investigator:
          • Liang Zhang
    • Ningxia
      • Yinchuan, Ningxia, China
        • General Hospital of Ningxia Medical University
        • Principal Investigator:
          • Lisha Na
      • Yinchuan, Ningxia, China
        • People's Hospital of Ningxia Hui Autonomous Region
        • Principal Investigator:
          • Guanghong Sun
    • Qinghai
      • Xining, Qinghai, China
        • Qinghai Provincial Cardiovascular and Cerebrovascular Disease Hospital
        • Principal Investigator:
          • Renbo Jin
    • Shaanxi
      • Xi'an, Shaanxi, China
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Principal Investigator:
          • Shun Wang
      • Xi'an, Shaanxi, China
        • Xi'an Central Hospital
        • Principal Investigator:
          • Yu Zheng
      • Xi'an, Shaanxi, China
        • Tangdu Hospital of Air Force Medical University
        • Principal Investigator:
          • Lijun Yuan
      • Xi'an, Shaanxi, China
        • Xijing Hospital of Air Force Medical University
        • Principal Investigator:
          • Xin Meng
    • Shandong
      • Jinan, Shandong, China
        • Jinan Central Hospital
        • Principal Investigator:
          • Lihua Jing
      • Jinan, Shandong, China
        • Qilu Hospital of Shandong University
        • Principal Investigator:
          • Yan Liu
      • Jinan, Shandong, China
        • The Fourth People's Hospital of Jinan Affiliated to Shandong Second Medical University
        • Principal Investigator:
          • Yongkun Chen
      • Jinan, Shandong, China
        • The Second Qilu Hospital of Shandong University
        • Principal Investigator:
          • Yongmei Wang
      • Jining, Shandong, China
        • The First People's Hospital of Jining
        • Principal Investigator:
          • Qingfeng Kong
      • Qingdao, Shandong, China
        • The Affiliated Hospital of Qingdao University
        • Principal Investigator:
          • Pin Sun
      • Qingdao, Shandong, China
        • Qilu Hospital of Shandong University
        • Principal Investigator:
          • Guihua Yao
      • Qingdao, Shandong, China
        • Qingdao Cardiovascular Hospital
        • Principal Investigator:
          • Min Lu
      • Qingdao, Shandong, China
        • Qingdao Central Hospital of University of Health and Rehabilitation Sciences
        • Principal Investigator:
          • Qing Xia
      • Qingdao, Shandong, China
        • Qingdao Haici Hospital Affiliated to Qingdao University
        • Principal Investigator:
          • Yong Liu
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Shanghai Chest Hospital
        • Principal Investigator:
          • Fan Li
      • Shanghai, Shanghai Municipality, China
        • Renji Hospital, Shanghai Jiao Tong University School of Medicine
        • Principal Investigator:
          • Zhiqing Qiao
    • Sichuan
      • Chengdu, Sichuan, China
        • West China Hospital of Sichuan University
        • Principal Investigator:
          • He Huang
      • Chengdu, Sichuan, China
        • The First Affiliated Hospital of Chengdu Medical College
        • Principal Investigator:
          • Jian Liu
      • Chengdu, Sichuan, China
        • The Second People's Hospital of Chengdu
        • Principal Investigator:
          • Yun Shi
      • Chengdu, Sichuan, China
        • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
        • Principal Investigator:
          • Lixue Yin
      • Chengdu, Sichuan, China
        • The First People's Hospital of Chengdu
        • Principal Investigator:
          • Shuang Li
      • Deyang, Sichuan, China
        • Deyang People's Hospital
        • Principal Investigator:
          • Xin Wei
      • Nanchong, Sichuan, China
        • Affiliated Hospital of North Sichuan Medical College
        • Principal Investigator:
          • Ling Li
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China
        • General Hospital of Tianjin Medical University
        • Principal Investigator:
          • Xin Du
    • Xinjiang
      • Ürümqi, Xinjiang, China
        • The First Affiliated Hospital of Xinjiang Medical University
        • Principal Investigator:
          • Yuming Mu
    • Yunnan
      • Kunming, Yunnan, China
        • The Second Affiliated Hospital of Kunming Medical University
        • Principal Investigator:
          • Juan Liu
      • Kunming, Yunnan, China
        • The First People's Hospital of Yunnan Province
        • Principal Investigator:
          • Fugang Mao
      • Kunming, Yunnan, China
        • Qujing Central Hospital of Yunnan Province
        • Principal Investigator:
          • Yan Cheng
      • Kunming, Yunnan, China
        • Yan'an Hospital Affiliated to Kunming Medical University
        • Principal Investigator:
          • Yunchuan Ding
  • Hong Kong
    • Hong Kong
      • Hong Kong, Hong Kong, Hong Kong
        • Queen Elizabeth Hospital
        • Principal Investigator:
          • Zhiyuan Huang
  • Taiwan
    • Taiwan
      • Taipei, Taiwan, Taiwan
        • Cheng Hsin General Hospital
        • Principal Investigator:
          • Mingchen Xiong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will comprise adults aged 18 years or older recruited from participating hospitals across China. Planned enrollment includes 1,600 patients with at least mild atrial secondary mitral regurgitation and 800 control participants. Controls will undergo clinically indicated transesophageal echocardiography and must have no significant cardiac structural or functional abnormalities on transthoracic echocardiography, with less than mild regurgitation of all cardiac valves. Participants will be screened according to the protocol-defined eligibility criteria.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Atrial Secondary Mitral Regurgitation Group

This group will include 1,600 adults aged 18 years or older with at least mild atrial secondary mitral regurgitation who meet the eligibility criteria. Participants will undergo transthoracic and three-dimensional transesophageal echocardiography to assess mitral valve structure, regurgitation severity, and cardiac function. Transesophageal echocardiography will be performed for clinical indications, without additional transesophageal examinations solely for research. Clinical follow-up will be conducted every three months.
Diagnostic test: 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.
Control Group

This group will include 800 adults aged 18 years or older undergoing clinically indicated transesophageal echocardiography. Transthoracic echocardiography must show no substantial structural or functional cardiac abnormalities, with less than mild regurgitation of all cardiac valves. Participants must meet the control-group eligibility criteria and have none of the exclusion criteria. Transthoracic and three-dimensional transesophageal echocardiographic images will be analyzed for comparison with the atrial secondary mitral regurgitation group.
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Heart Failure Rehospitalization
Time Frame: 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.
From enrollment through 12 months
Number of Participants With Cardiovascular Death
Time Frame: 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.
From enrollment through 12 months
Number of Participants Undergoing Mitral Valve Intervention
Time Frame: 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.
From enrollment through 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Hospital of China Medical University

Collaborators

Sichuan Academy of Medical Sciences
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Investigators

  • Principal Investigator: Chunyan Ma, Ph.D., First Hospital of China Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

November 30, 2028

Study Registration Dates

First Submitted

October 30, 2026

First Submitted That Met QC Criteria

October 31, 2026

First Posted (Actual)

November 5, 2026

Study Record Updates

Last Update Posted (Actual)

November 5, 2026

Last Update Submitted That Met QC Criteria

October 31, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMR-3DTEE-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is currently no plan to share individual participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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