IntraCardiac Echocardiography sysTem

NCT06392243 | Completed

• 1 other identifier: UC002
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Diseases

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Experimental group

EXPERIMENTAL

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.

Device: Intracardiac ultrasound imaging system

Control Group

ACTIVE COMPARATOR

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

Device: Intracardiac ultrasound imaging system

Interventions

Intracardiac ultrasound imaging system DEVICE

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

Control Group; Experimental group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged ≥18 years and ≤85 years, regardless of gender,
• patients who planned to undergo intracardiac and macrovascular imaging, intracardiac Doppler flow assessment, and intracardiac intervention,
• 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.

You may not qualify if:

• known complication of sepsis, thrombosis or severe peripheral vascular disease;
• angina class IV CCS or NYHA Class IV cardiac function,
• severe Coagulopathy unable to perform vascular puncture,
• known to be severely allergic to the materials used in the study;
• pregnant or lactating women, or those who had planned to become pregnant during the trial;
• those who were enrolled in any other drug or medical device clinical trial and had not yet left the group;
• other conditions that the investigator judged unsuitable for enrollment.

Sponsors & Collaborators

• Sonosemi Medical Co., Ltd.: lead

Study Sites (1)

Sonosemi Medical Co., Ltd.

Shenzhen, Guangdong, China

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• He Ben

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

• Chu Huimin

  Ningbo No. 1 Hospital

  PRINCIPAL INVESTIGATOR

• Li Haiying

  The University of Hong Kong-Shenzhen Hospital

  PRINCIPAL INVESTIGATOR

• Ma Wei

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

• Ning Zhongping

  Zhoupu Hospital, Pudong New Area, Shanghai, China

  PRINCIPAL INVESTIGATOR

• Zhang Xiwen

  Huai'an First People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 30, 2024
• Study Start: October 22, 2022
• Primary Completion: October 23, 2023
• Study Completion: December 23, 2023
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)