The Cardiac Intervention Imaging Clinical Trial of an Intracardiac Ultrasound Catheter and Ultrasound System
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 试验地点
- 4
- 主要终点
- Image quality
研究概览
简要总结
The INTELICE trial is a prospective, multicenter, 1:1 randomized controlled non-inferiority study. It aims to compare a novel intracardiac echography (ICE) catheter and combined ultrasound system with existing commercial ones. The evaluation will be conducted on patients undergoing planned intracardiac interventional process.
详细描述
This randomized controlled trial will enroll adult patients undergoing cardiac interventions, who will be randomly assigned to either the experimental device group or the control group.
The main endpoint of the INTELICE trial is the image quality rate of intracardiac echocardiography, which will be evaluated by three experienced sonographers from the core laboratory, while the operator's image quality assessment serves as a secondary endpoint. In addition, secondary endpoints include clinical success rate, technical success rate, procedure time, and evaluation for the experimental devices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years, ≤90 years, of any gender.
- •Subjects deemed suitable for the utilization of ICE catheters during cardiac interventional procedures, as determined by investigators:
- •Requirement for ICE imaging of the heart;
- •Requirement for ICE imaging of great vessels;
- •Requirement for ICE imaging of other intracardiac devices.
- •Subjects themselves or their guardians must possess the ability to comprehend the purpose of this study, demonstrate adequate compliance with the protocol, and sign the informed consent form.
排除标准
- •Anticipated vascular access (e.g., femoral vein, inferior vena cava, subclavian vein, internal jugular vein) cannot meet the procedure needs.
- •PLT <100*109/L or INR >1.
- •Intracardiac blood clots or severe peripheral vascular disease (e.g., deep vein thrombosis, aneurysm, atherosclerosis).
- •Sepsis, pyemia, or severe systemic infection.
- •NYHA Class IV.
- •History of cardiac or related cardiac areas surgery within 6 months.
- •Inability to tolerate post procedure oral anticoagulants or antiplatelet drugs.
- •Inability to tolerate or cooperate with the procedure.
- •Pregnant or lactating women, women with a positive pregnancy test result within 7 days before enrollment.
- •Participation in other clinical trials of drugs, biological agents or devices within 3 months before screening.
- •Other exclusive circumstances determined by the investigators, where the subject is deemed unsuitable for enrollment.
结局指标
主要结局
Image quality
时间窗: Up to 6 months
The image quality will be assessed by three cardiac sonographers. Sonographers will score based on image parameters such as image clarity, penetration, temporal and spatial resolution, blood flow, etc. The evaluation with utilize a 1-5 scale scoring system. A score of 5 indicates that the images are excellent and suitable for clinical needs, while a score of 4 suggests good quality. 3 indicates that the image has flaws but still meets the clinical needs. Scores of 1 and 2 signify poor or bad image quality, which can affect clinical diagnosis and treatment.
次要结局
- Procedure time(Up to 24 hours)
- Technical success(Up to 24 hours)
- Image quality(Up to 48 hours)
- Procedure success(Up to 24 hours)