An observational study in Mitral Valve Insufficiency, sponsored by First Hospital of China Medical University. Not yet recruiting at 93 sites in 3 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by First Hospital of China Medical University · Observational
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.
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.
468 studies on the registry are indexed under Mitral Valve Insufficiency; 164 are open to participants now.
This study's planned enrollment of 2,400 is above the median of 157 across 168 observational studies indexed under Mitral Valve Insufficiency.
Browse Mitral Valve Insufficiency studies →First Hospital of China Medical University is the lead sponsor of 62 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Atrial Secondary Mitral Regurgitation Group:
At least mild atrial secondary mitral regurgitation, meeting all of the following criteria:
Control Group:
All participants must meet the inclusion criteria for their respective group and provide written .
Exclusion Criteria:
The following exclusion criteria apply to both groups:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
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.
Time frame: From enrollment through 12 months
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.
Time frame: From enrollment through 12 months
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.
Time frame: From enrollment through 12 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — There is currently no plan to share individual participant data.
Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.
Of 72 non-industry observational studies under Mitral Valve Insufficiency, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 192. This study's planned 12 months is below that.
Counting every sponsor, half of 84 studies reached it within 57 months; a quarter within 26 and three quarters within 192.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
First Hospital of China Medical University