Cardiac Interventional ICE Imaging Trial

Launched by ICE INTELLIGENT HEALTHCARE CO., LTD · Mar 27, 2024

Keywords

ClinConnect Summary

The Cardiac Interventional ICE Imaging Trial is a research study designed to compare a new type of heart imaging tool called an intracardiac echography (ICE) catheter with existing devices used during heart procedures. This trial focuses on patients who have various heart conditions, such as heart valve problems, atrial septal defects, and arrhythmias. The goal is to see if the new tool works just as well as the current ones, which will help doctors make better decisions during treatments.

To participate in this trial, individuals must be between 18 and 90 years old and are expected to need ICE imaging during their heart procedures. They should also be able to understand the study’s purpose and agree to participate. However, certain health conditions, like severe infections or recent heart surgeries, may prevent someone from joining. Participants will undergo the planned heart procedure with the imaging tool and will be closely monitored for their safety and the effectiveness of the new device. This trial is not yet recruiting participants, but it aims to provide valuable insights into improving heart procedures in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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:
• • 1. Requirement for ICE imaging of the heart;
• • 2. Requirement for ICE imaging of great vessels;
• • 3. 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.
• Exclusion Criteria:
• • 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 \>1.5.
• • 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.