Clinical trial NCT06392243: IntraCardiac Echocardiography sysTem
Official title: Prospective, Multicenter, ranDomized Controlled, Non-Inferior Clinical Trial to Evaluate the SafeTy and effIcacy of a Novel intraCardiac Echocardiography sysTem（DISTINCT Trial）
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Diseases
Lead sponsor: Sonosemi Medical Co., Ltd.
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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.

Primary outcomes:
measure: Excellent rate of image
timeFrame: 0 days after the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Sonosemi Medical Co., Ltd.
state: Guangdong
Study officials:
affiliation: Shanghai Chest Hospital
name: He Ben
role: PRINCIPAL_INVESTIGATOR
affiliation: Ningbo No. 1 Hospital
name: Chu Huimin
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Hong Kong-Shenzhen Hospital
name: Li Haiying
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University First Hospital
name: Ma Wei
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhoupu Hospital, Pudong New Area, Shanghai, China
name: Ning Zhongping
role: PRINCIPAL_INVESTIGATOR
affiliation: Huai'an First People's Hospital
name: Zhang Xiwen
role: PRINCIPAL_INVESTIGATOR
References: