Valvular Heart DiseaseNCT07603115
Diagnostic Study of Structural Heart Disease Based on Cardiac Electromechanical Signals
An observational study of Valvular Heart Disease, run by First Affiliated Hospital Xi'an Jiaotong University.
Trial summary
Study participants will be prospectively recruited from consecutive outpatient and inpatient populations presenting to the Cardiology and Cardiac Surgery Departments of the following participating institutions: The First Affiliated Hospital of Xi'an Jiaotong University, The Second Affiliated Hospital of Xi'an Jiaotong… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Valvular Heart Disease
- What is being tested?
- Transthoracic Echocardiography
- How many people
- 1,300 participants
- Where
- No sites listed yet
- Study dates
- May 2026to Dec 2027
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study sample will be recruited from outpatient and inpatient populations in the cardiology and cardiac surgery departments of multiple participating centers, covering patients with valvular heart disease of various types and severity levels, as well as healthy individuals or those undergoing routine health check-ups as controls. Specifically, the case group consists of patients aged ≥ 18 years with valvular lesions confirmed by transthoracic echocardiography and who can complete speckle tracking echocardiography, while the control group includes individuals with normal cardiac valves and no other cardiovascular diseases confirmed by echocardiography.
Who may be able to join
- - Aged ≥ 18 years.
- For the case group: Presence of valvular lesions confirmed by transthoracic echocardiography.
- For the control group: Normal cardiac valves and no evidence of other cardiovascular diseases confirmed by transthoracic echocardiography.
- Ability to undergo and complete speckle tracking echocardiography.
Who cannot join
- Patients who are unwilling to participate in this study.
- Patients with a known allergy to the electrode patches or medical adhesive tapes used in this study.
- Patients who are unable to cooperate with the completion of required examinations.
- Patients with incomplete clinical or imaging data that cannot be supplemented.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Study participants will be prospectively recruited from consecutive outpatient and inpatient populations presenting to the Cardiology and Cardiac Surgery Departments of the following participating institutions: The First Affiliated Hospital of Xi'an Jiaotong University, The Second Affiliated Hospital of Xi'an Jiaotong University, and [add additional participating institutions as applicable].
- Conditions
- Valvular Heart Disease
- Being tested
- Transthoracic Echocardiography
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic EchocardiographyDiagnostic test
All patients in the case group undergo transthoracic echocardiography to assess valvular structure and function, which is the core diagnostic intervention for valvular lesions.
| Study group | Role | What they receive |
|---|---|---|
| Valvular Lesions | Case Group Receives: Diagnostic Test: Transthoracic Echocardiography | |
| Case Group (Valvular Lesions) | This group consists of 960 cases covering 24 valvular lesion subtypes (40 cases per subtype), designed for exploratory comparative analysis of each subtype. Receives: Diagnostic Test: Transthoracic Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy (Sensitivity and Specificity) of the Novel Assay for Valvular Heart Disease
Demonstrates the diagnostic detection performance of the novel assay in identifying patients with valvular heart disease, measured by sensitivity and specificity against the reference standard .This outcome reflects the assay's ability to detect valvular lesions across 24 distinct subtypes.
Measured: Baseline (At the time of initial diagnostic testing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study startMay 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valvular Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital of Xi'an Jiaotong University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603115
- Sponsor's protocol ID
- ABC202511
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Study of Structural Heart Disease Based on Cardiac Electromechanical Signals
- ClinicalTrials.gov ID
- NCT07603115
- Acronym / sponsor ID
- ABC202511
- Conditions
- Valvular Heart Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital of Xi'an Jiaotong University
- Study start
- May 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study participants will be prospectively recruited from consecutive outpatient and inpatient populations presenting to the Cardiology and Cardiac Surgery Departments of the following participating institutions: The First Affiliated Hospital of Xi'an Jiaotong University, The Second Affiliated Hospital of Xi'an Jiaotong University, and [add additional participating institutions as applicable].
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Valvular Lesions | – | Diagnostic Test: Transthoracic EchocardiographyCase Group |
| Case Group (Valvular Lesions) | – | Diagnostic Test: Transthoracic EchocardiographyThis group consists of 960 cases covering 24 valvular lesion subtypes (40 cases per subtype), designed for exploratory comparative analysis of each subtype. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study sample will be recruited from outpatient and inpatient populations in the cardiology and cardiac surgery departments of multiple participating centers, covering patients with valvular heart disease of various types and severity levels, as well as healthy individuals or those undergoing routine health check-ups as controls. Specifically, the case group consists of patients aged ≥ 18 years with valvular lesions confirmed by transthoracic echocardiography and who can complete speckle tracking echocardiography, while the control group includes individuals with normal cardiac valves and no other cardiovascular diseases confirmed by echocardiography.
Key inclusion criteria (4 listed)
- - Aged ≥ 18 years.
- For the case group: Presence of valvular lesions confirmed by transthoracic echocardiography.
- For the control group: Normal cardiac valves and no evidence of other cardiovascular diseases confirmed by transthoracic echocardiography.
- Ability to undergo and complete speckle tracking echocardiography.
Key exclusion criteria (4 listed)
- Patients who are unwilling to participate in this study.
- Patients with a known allergy to the electrode patches or medical adhesive tapes used in this study.
- Patients who are unable to cooperate with the completion of required examinations.
- Patients with incomplete clinical or imaging data that cannot be supplemented.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transthoracic EchocardiographyAll patients in the case group undergo transthoracic echocardiography to assess valvular structure and function, which is the core diagnostic intervention for valvular lesions. | Diagnostic test | Case Group (Valvular Lesions), Valvular Lesions |
Primary outcome
Diagnostic Accuracy (Sensitivity and Specificity) of the Novel Assay for Valvular Heart Disease
Time frame: Baseline (At the time of initial diagnostic testing)
Demonstrates the diagnostic detection performance of the novel assay in identifying patients with valvular heart disease, measured by sensitivity and specificity against the reference standard .This outcome reflects the assay's ability to detect valvular lesions across 24 distinct subtypes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Valvular Heart Disease, run by First Affiliated Hospital Xi'an Jiaotong University.
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 4 inclusion and 4 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 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Hui Yi Xiao, MD (+86-029-85323816, sbw_514@163.cpom), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy (Sensitivity and Specificity) of the Novel Assay for Valvular Heart Disease (time frame: Baseline (At the time of initial diagnostic testing)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2026.