IntraCardiac Echocardiography sysTem (DISTINCT)

Sonosemi Medical Co., Ltd.

Status: Completed

Conditions: Heart Diseases

Treatments: Device: Intracardiac ultrasound imaging system

Study type: Interventional

Funder types: Other

Identifiers

NCT06392243

UC002

Details and patient eligibility

About

To evaluate the safety and effectiveness of intracardiac ultrasound imaging system in Sonosemi Medical Co., Ltd.

Full 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

Enrollment: 134 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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134 participants in 2 patient groups

Experimental group

Experimental group

Description:

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.

Treatment:

Device: Intracardiac ultrasound imaging system

Control Group

Active Comparator group

Description:

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

Treatment:

Device: Intracardiac ultrasound imaging system