Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
134 participants
INTERVENTIONAL
2022-10-22
2023-12-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Experimental group
In the experimental group, intracardiac and large blood vessel imaging, intracardiac Doppler flow assessment and guidance of intracardiac intervention were performed by intracardiac ultrasound imaging system of Sonosemi Medical Co., Ltd.
Intracardiac ultrasound imaging system
The control group was treated with SOUNDSTAR 3D Diagnostic Ultrasound catheter (SNDSTR10G) and Vivid IQ, intracardiac and macrovascular imaging of the heart, assessment of intracardiac Doppler flow, and guidance for intracardiac intervention
Control Group
The control group was treated with SOUNDSTAR 3D Diagnostic Ultrasound catheter (SNDSTR10G) and Vivid IQ, intracardiac and macrovascular imaging of the heart, assessment of intracardiac Doppler flow, and guidance for intracardiac intervention
Intracardiac ultrasound imaging system
The control group was treated with SOUNDSTAR 3D Diagnostic Ultrasound catheter (SNDSTR10G) and Vivid IQ, intracardiac and macrovascular imaging of the heart, assessment of intracardiac Doppler flow, and guidance for intracardiac intervention
Interventions
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Intracardiac ultrasound imaging system
The control group was treated with SOUNDSTAR 3D Diagnostic Ultrasound catheter (SNDSTR10G) and Vivid IQ, intracardiac and macrovascular imaging of the heart, assessment of intracardiac Doppler flow, and guidance for intracardiac intervention
Eligibility Criteria
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Inclusion Criteria
2. patients who planned to undergo intracardiac and macrovascular imaging, intracardiac Doppler flow assessment, and intracardiac intervention,
3. subjects who could understand the purpose of the trial, were willing to cooperate with interventional treatment and follow-up, participated in the trial voluntarily and signed a written informed consent.
Exclusion Criteria
2. angina class IV CCS or NYHA Class IV cardiac function,
3. severe Coagulopathy unable to perform vascular puncture,
4. known to be severely allergic to the materials used in the study;
5. pregnant or lactating women, or those who had planned to become pregnant during the trial;
6. those who were enrolled in any other drug or medical device clinical trial and had not yet left the group;
7. other conditions that the investigator judged unsuitable for enrollment.
18 Years
85 Years
ALL
Yes
Sponsors
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Sonosemi Medical Co., Ltd.
OTHER
Responsible Party
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Principal Investigators
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He Ben
Role: PRINCIPAL_INVESTIGATOR
Shanghai Chest Hospital
Chu Huimin
Role: PRINCIPAL_INVESTIGATOR
Ningbo No. 1 Hospital
Li Haiying
Role: PRINCIPAL_INVESTIGATOR
The University of Hong Kong-Shenzhen Hospital
Ma Wei
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Ning Zhongping
Role: PRINCIPAL_INVESTIGATOR
Zhoupu Hospital, Pudong New Area, Shanghai, China
Zhang Xiwen
Role: PRINCIPAL_INVESTIGATOR
Huai'an First People's Hospital
Locations
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Sonosemi Medical Co., Ltd.
Shenzhen, Guangdong, China
Countries
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Other Identifiers
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UC002
Identifier Type: -
Identifier Source: org_study_id