the function of Bileaflet Mechanical Heart Valve in patients
Conditions
Interventions
Gold Standard:The clinical diagnosis results obtained from the same subject undergoing transthoracic echocardiography (+transesophageal echocardiography or cardiac CT) examination
Generally, when the image quality of transthoracic echocardiography is unclear, difficult to identify, and cannot be clearly diagnosed clinically, subjects need to undergo transesophageal echocardiogr
Only when there is a clear clinical diagnosis on transthoracic echocardiography, but the examination results are inconsistent with those of mechanical heart valve detectors
Index test:Mechanical Heart Valve Tester (TC-2, Xiongzhi Medical Equipment Technology (Suzhou) Co., Ltd.)
Sponsors
Beijing Anzhen Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Age = 18 years old, regardless of gender; (2) Implant 1-2 Bileaflet Mechanical Heart Valves subjects; (3) The subjects or their guardians are able to understand the research purpose, demonstrate sufficient compliance with the research protocol, and sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients who have implanted a single leaflet valve; (2) Patients with severe infections, allergies, scars, or skin diseases on the skin of the precordial region; (3) Patients who require support from mechanical noise equipment such as ventilators; (4) Patients with implantation of two leaflets and arrhythmia; (5) The subjects are pregnant or lactating women; (6) Participated in clinical trials of other intervention drugs, biologics, or devices within one month prior to screening; (7) Other situations that the researcher determines are not suitable for selection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The total coincidence rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity;Kappa;Positive predictive value;Negative predictive value;Satisfaction evaluation;Adverse event occurrence rate;Serious adverse event incidence rate;Medical device defect incidence rate; | — |
Countries
China
Contacts
Public ContactHaibo Zhang
Beijing Anzhen Hospital Affiliated to Capital Medical University
Outcome results
None listed