Diagnostic Study of Structural Heart Disease Based on Cardiac Electromechanical Signals

NCT07603115 | Not Yet Recruiting FDA Device

• 1 other identifier: ABC202511
• Study Type: observational
• Target: 1,300
• Locations: 0 countries
• Sites: N/A

Brief 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 University, and \[add additional participating institutions as applicable\].

Conditions

Valvular Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (At the time of initial diagnostic testing)

Study Arms (2)

Valvular Lesions

Case Group

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.

Diagnostic Test: Transthoracic Echocardiography

Interventions

Transthoracic Echocardiography DIAGNOSTIC_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.

Case Group (Valvular Lesions); Valvular Lesions

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Second Affiliated Hospital of Xi'an Jiaotong University: collaborator

MeSH Terms

Conditions

Heart Valve Diseases

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Central Study Contacts

Hui Yi Xiao, MD

CONTACT

+86-029-85323816; sbw_514@163.cpom

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 22, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share