NCT06392243

IntraCardiac Echocardiography sysTem

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Sonosemi Medical Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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

Conditions

• Heart Diseases

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-10-22
• Primary completion: 2023-10-23
• Completion: 2023-12-23
• First posted: 2024-04-30
• Last updated: 2024-04-30

Locations

1 site across 1 country: China