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Subjects who are required to undergo transesophageal echocardiography according to the current clinical practice standards will be eligible for enrollment. Subjects will be screened for enrollment in this study against the inclusion and exclusion criteria. After successful screening and enrollment of subjects, the investigators will first use the investigational device to conduct transthoracic echocardiography (TTE), followed by transesophageal echocardiography (TEE). TEE will be conducted after the subject has been anesthetized. To avoid any delay in diagnosis and treatment, after the scan with the investigational device is completed, the probe will be reserved and the console will be switched to the existing commercial cardiac diagnostic ultrasound device in the study site for intraoperative guidance. In the study, each investigator will evaluate the overall image quality, user interface, workflow, user preferences, product preset, and functions of the system, as well as the device's safety and stability and fill out a user feedback questionnaire provided by the Sponsor.
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| Measure | Description | Time Frame |
|---|---|---|
| The main evaluation indicators include Overall system operation, Reliability, System operability, Overall image quality, etc., and the evaluation results are represented by five grades: Excellent, Very good, Good, Bad, and Very bad. | From enrollment to Day 1 (Visit 1) |
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| Measure | Description | Time Frame |
|---|---|---|
| The other evaluation indicators include Imaging Mode , Structural Heart Disease Workflow Productivity Tools, FlexiSlice Improvements , The results are expressed as a score (5 to 1 point), with higher scores indicating better performance | From enrollment to Day1(Visit1) |
Inclusion Criteria:
Exclusion Criteria:
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Subjects who are required to undergo intraoperative transesophageal echocardiography according to the current clinical practice standards;
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan Zhang | Contact | +86 18951670387 | yinyinye9157793@126.com | |
| Zhihui Z Zhang, Zhi | Contact | +86 18531524215 | zhihui.zhang2@gehealthcare.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing First Hospital, Nanjing Medical University | Recruiting | Nanjing | China |
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