IntraCardiac Echocardiography sysTem

Not Applicable

Completed

• Conditions: Heart Diseases
• Interventions: Device: Intracardiac ultrasound imaging system

• Registration Number: NCT06392243
• Lead Sponsor: Sonosemi Medical Co., Ltd.

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

Study Timeline

• Study Start: 2022-10-22
• Primary Completion: 2023-10-23
• Study Completion: 2023-12-23
• Status Verified: 2024-04
• Study First Submitted: 2024-04-23
• Study First Submitted QC: 2024-04-25
• Last Update Submitted: 2024-04-25
• Study First Posted: 2024-04-30
• Last Update Posted: 2024-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	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
Experimental group	Intracardiac ultrasound imaging system	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.

Primary Outcome Measures

Name	Time	Method
Excellent rate of image	0 days after the operation	In intracardiac and large-vessel endocardial imaging of the heart, the researchers determined the ratio of"Excellent" to"Good" ultrasound image quality

Trial Locations

Locations (1)

Sonosemi Medical Co., Ltd.; 🇨🇳 Shenzhen, Guangdong, China