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Mitral Valve InsufficiencySMR-3DTEENCT07918937

Multi-center Study of Three-Dimensional Transesophageal Echocardiography in Patients With Secondary Mitral Regurgitation

An observational study of Mitral Valve Insufficiency, run by First Hospital of China Medical University at 93 sites in 3 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Mitral Valve Insufficiency
What is being tested?
Transthoracic and Three-Dimensional Transesophageal Echocardiography
How many people
2,400 participants
Where
93 sitesin 3 countries
Study dates
1 Nov 2026to 30 Nov 2028
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • Atrial Secondary Mitral Regurgitation Group:
  • Age 18 years or older.
  • 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:
Show all 17Show fewer
  • 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.
  • Undergoing both transthoracic and transesophageal echocardiography, with standardized images retained.
  • Control Group:
  • Age 18 years or older.
  • Undergoing transesophageal echocardiography for clinical indications, such as suspected patent foramen ovale or infective endocarditis.
  • 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.

Who cannot join

  • The following exclusion criteria apply to both groups:
  • Primary mitral regurgitation caused by organic mitral valve disease, including degenerative changes, rheumatic involvement, congenital mitral valve abnormalities, or vegetations.
  • Moderate or greater aortic valve disease.
  • Previous cardiac valve surgery or catheter-based valve intervention.
  • Congenital heart disease.
  • Inadequate three-dimensional transesophageal echocardiographic image quality that precludes reliable assessment of mitral valve structure and motion.
  • Contraindications to, or inability to tolerate, transesophageal echocardiography.
  • Refusal to provide written informed consent.

Trial locations and contacts

93 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Chunyan Ma, Ph.D. contact

+86 13998816448

cmu1h_mcy@126.com

93 sites in 3 countries

China91 sites

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin

    Hui Wang

  • First Hospital of Jilin University

    Changchun, Jilin

    Hui Xu

  • Second Hospital of Jilin University

    Changchun, Jilin

    Dongmei Lyu

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

    Qin Wu

  • Chaoyang Central Hospital

    Chaoyang, Liaoning

    Hong Zhou

  • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

    Chengdu, Sichuan

    Lixue Yin

  • The First Affiliated Hospital of Chengdu Medical College

    Chengdu, Sichuan

    Jian Liu

  • The First People's Hospital of Chengdu

    Chengdu, Sichuan

    Shuang Li

  • The Second People's Hospital of Chengdu

    Chengdu, Sichuan

    Yun Shi

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

    He Huang

  • Chongqing Emergency Medical Center

    Chongqing, Chongqing Municipality

    Yan Du

  • Southwest Hospital of Army Medical University

    Chongqing, Chongqing Municipality

    Yanli Guo

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

    Qian Dong

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

    Jianli Ren

  • Xinqiao Hospital of Army Medical University

    Chongqing, Chongqing Municipality

    Hongmei Xia

  • Dalian Central Hospital Affiliated to Dalian University of Technology

    Dalian, Liaoning

    Yu Dong

  • Deyang People's Hospital

    Deyang, Sichuan

    Xin Wei

  • Minda Hospital of Hubei Minzu University

    Enshi, Hubei

    Gongquan Chen

  • Fujian Medical University Union Hospital (Qishan Campus)

    Fuzhou, Fujian

    Xudong Sun

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong

    Hongwen Fei

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong

    Juefei Wu

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong

    Fengjuan Yao

  • Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou

    Shaomei Yu

  • Guizhou Provincial People's Hospital

    Guiyang, Guizhou

    Yaning Chen

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

    Danyang Yu

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

    Hairu Li

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

    Sining Hu

  • The Second Hospital of Harbin

    Harbin, Heilongjiang

    Fangfang Zhu

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

    Xuegong Shi

  • The First Affiliated Hospital of University of South China

    Hengyang, Hunan

    Jia Zhou

  • Huangshi Central Hospital

    Huangshi, Hubei

    Zhian Hu

  • Jinan Central Hospital

    Jinan, Shandong

    Lihua Jing

  • Qilu Hospital of Shandong University

    Jinan, Shandong

    Yan Liu

  • The Fourth People's Hospital of Jinan Affiliated to Shandong Second Medical University

    Jinan, Shandong

    Yongkun Chen

  • The Second Qilu Hospital of Shandong University

    Jinan, Shandong

    Yongmei Wang

  • Jingmen Central Hospital

    Jingmen, Hubei

    Xueying Chen

  • Jingzhou Central Hospital

    Jingzhou, Hubei

    Qiang Zhang

  • The First People's Hospital of Jining

    Jining, Shandong

    Qingfeng Kong

  • The First Affiliated Hospital of Jinzhou Medical University

    Jinzhou, Liaoning

    Lili Ge

  • Qujing Central Hospital of Yunnan Province

    Kunming, Yunnan

    Yan Cheng

  • The First People's Hospital of Yunnan Province

    Kunming, Yunnan

    Fugang Mao

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan

    Juan Liu

  • Yan'an Hospital Affiliated to Kunming Medical University

    Kunming, Yunnan

    Yunchuan Ding

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu

    Lu Zhang

  • Liaoyang Central Hospital

    Liaoyang, Liaoning

    Ying Guo

  • The First Affiliated Hospital of Guangxi University of Science and Technology

    Liuzhou, Guangxi

    Gaoxing Wang

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

    Xinchun Yuan

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

    Chunquan Zhang

  • Affiliated Hospital of North Sichuan Medical College

    Nanchong, Sichuan

    Ling Li

  • Jiangsu Province Hospital (The First Affiliated Hospital of Nanjing Medical University)

    Nanjing, Jiangsu

    Yonghong Yong

  • Jiangsu Province Hospital of Chinese Medicine

    Nanjing, Jiangsu

    Anxia He

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi

    Ji Wu

  • Qilu Hospital of Shandong University

    Qingdao, Shandong

    Guihua Yao

  • Qingdao Cardiovascular Hospital

    Qingdao, Shandong

    Min Lu

  • Qingdao Central Hospital of University of Health and Rehabilitation Sciences

    Qingdao, Shandong

    Qing Xia

  • Qingdao Haici Hospital Affiliated to Qingdao University

    Qingdao, Shandong

    Yong Liu

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong

    Pin Sun

  • Renji Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality

    Zhiqing Qiao

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality

    Fan Li

  • Shantou Central Hospital

    Shantou, Guangdong

    Liangyu Wang

  • First Hospital of China Medical University

    Shenyang, Liaoning, 110001

    Chunyan Ma, Ph.D., +86 13998816448, cmu1h_mcy@126.com

    Chunyan Ma, Ph.D.

  • Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

    Shenyang, Liaoning

    Liang Zhang

  • Fuwai Hospital, Chinese Academy of Medical Sciences Shenzhen Hospital

    Shenzhen, Guangdong

    Yong Jiang

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei

    Wugang Wang

  • The Second Hospital of Hebei Medical University (Luquan Campus)

    Shijiazhuang, Hebei

    Yajing Miao

  • Sinopharm Dongfeng General Hospital Affiliated to Hubei University of Medicine

    Shiyan, Hubei

    Haiyan Wu

  • Taihe Hospital of Shiyan

    Shiyan, Hubei

    Dingfang Yan

  • General Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality

    Xin Du

  • The First People's Hospital of Tianshui

    Tianshui, Gansu

    Maolin Wu

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang

    Yuming Mu

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei

    Qing Zhou

  • The Sixth Hospital of Wuhan Affiliated to Jianghan University

    Wuhan, Hubei

    Aihua Liu

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei

    Yani Liu

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei

    Mingxing Xie

  • Wuhan Asia Heart Hospital

    Wuhan, Hubei

    Xiaojing Ma

  • Wuhan Central Hospital

    Wuhan, Hubei

    Fengxia Jiang

  • Wuhan First Hospital

    Wuhan, Hubei

    Jia Ge

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei

    Bin Wang

  • Wuxi Hospital of Traditional Chinese Medicine

    Wuxi, Jiangsu

    Lingjun Li

  • Wuxi People's Hospital (Wuxi People's Hospital Affiliated to Nanjing Medical University)

    Wuxi, Jiangsu

    Jun Tan

  • Tangdu Hospital of Air Force Medical University

    Xi'an, Shaanxi

    Lijun Yuan

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi

    Shun Wang

  • Xi'an Central Hospital

    Xi'an, Shaanxi

    Yu Zheng

  • Xijing Hospital of Air Force Medical University

    Xi'an, Shaanxi

    Xin Meng

  • Qinghai Provincial Cardiovascular and Cerebrovascular Disease Hospital

    Xining, Qinghai

    Renbo Jin

  • Yichang Central People's Hospital

    Yichang, Hubei

    Chang Zhou

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia

    Lisha Na

  • People's Hospital of Ningxia Hui Autonomous Region

    Yinchuan, Ningxia

    Guanghong Sun

  • The First People's Hospital of Yulin

    Yulin, Guangxi

    Yuxuan Luo

  • Zhangzhou Hospital of Fujian Province

    Zhangzhou, Fujian

    Shuping Yang

  • Fuwai Central China Cardiovascular Hospital

    Zhengzhou, Henan

    Juan Cong

Other trials in China

Hong Kong1 site

  • Queen Elizabeth Hospital

    Hong Kong, Hong Kong

    Zhiyuan Huang

Other trials in Hong Kong

Taiwan1 site

  • Cheng Hsin General Hospital

    Taipei, Taiwan

    Mingchen Xiong

Other trials in Taiwan

About this study

Official title: 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.

Read the 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.

Being tested
Transthoracic and Three-Dimensional Transesophageal Echocardiography
Keywords
Secondary Mitral Regurgitation, Atrial Secondary Mitral Regurgitation, Three-Dimensional Transesophageal Echocardiography, Transthoracic Echocardiography, Mitral Valve Geometry, Left Ventricular Function
Medical subject headings
Mitral Valve Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transthoracic and Three-Dimensional Transesophageal EchocardiographyDiagnostic test

    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 groups in NCT07918937
Study groupRoleWhat they receive
Atrial Secondary Mitral Regurgitation GroupThis 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.
Receives: Diagnostic Test: Transthoracic and Three-Dimensional Transesophageal Echocardiography
Control GroupThis 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.
Receives: Diagnostic Test: Transthoracic and Three-Dimensional Transesophageal Echocardiography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Heart Failure Rehospitalization

    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.

    Measured: From enrollment through 12 months

  2. Number of Participants With Cardiovascular Death

    Number of participants who die from cardiovascular causes during follow-up. Outcome information will be collected through follow-up and checked against medical records.

    Measured: From enrollment through 12 months

  3. Number of Participants Undergoing Mitral Valve Intervention

    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.

    Measured: From enrollment through 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2026
  2. Study start1 Nov 2026 (estimated)
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion30 Nov 2028 (estimated)

Resources

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
Prospective
Enrolment
2,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07918937
Sponsor's protocol ID
SMR-3DTEE-01
Acronym
SMR-3DTEE
Status last verified
Oct 2026
First submitted
30 Oct 2026
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is currently no plan to share individual participant data.

Questions about this trial

What is this clinical trial studying?

An observational study of Mitral Valve Insufficiency, run by First Hospital of China Medical University at 93 sites in 3 countries.

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 17 inclusion and 8 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: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 sites in China, Hong Kong, Taiwan. 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?

Contact Chunyan Ma, Ph.D. (+86 13998816448, cmu1h_mcy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Heart Failure Rehospitalization (time frame: From enrollment through 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07918937.

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 5 Nov 2026.

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