IntraCardiac Echocardiography sysTem

Heart Diseases Clinical Trial

— DISTINCT  

Official title:

Prospective, Multicenter, ranDomized Controlled, Non-Inferior Clinical Trial to Evaluate the SafeTy and effIcacy of a Novel intraCardiac Echocardiography sysTem（DISTINCT Trial）

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06392243
• Other study ID #: UC002
• Status: Completed
• Phase: N/A
• Start date: October 22, 2022
• Est. completion date: December 23, 2023

Study information

• Verified date: April 2024
• Source: Sonosemi Medical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: December 23, 2023
• Est. primary completion date: October 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Diseases

Intervention

Device:
• 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

Locations

Country	Name	City	State
China	Sonosemi Medical Co., Ltd.	Shenzhen	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sonosemi Medical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Excellent rate of image	In intracardiac and large-vessel endocardial imaging of the heart, the researchers determined the ratio of"Excellent" to"Good" ultrasound image quality	0 days after the operation