Heart Diseases
Conditions
Brief summary
To evaluate the safety and effectiveness of intracardiac ultrasound imaging system in Sonosemi Medical Co., Ltd.
Detailed description
A prospective, multicenter, randomized controlled, non-inferiority clinical trial was designed. 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. 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. After meeting the entry criteria, they will be randomized by an electronic randomization system, and the researchers will conduct a clinical trial based on the results of the randomization, intracardiac and large vessel imaging, intracardiac Doppler flow assessment, and guidance of intracardiac intervention were performed in both groups
Interventions
DEVICEIntracardiac 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
Sponsors
Sonosemi Medical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. patients aged ≥18 years and ≤85 years, regardless of gender, 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
1. known complication of sepsis, thrombosis or severe peripheral vascular disease; 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Excellent rate of image | 0 days after the operation | In intracardiac and large-vessel endocardial imaging of the heart, the researchers determined the ratio ofExcellent toGood ultrasound image quality |
Countries
China
Outcome results
None listed