Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT06344494
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT06344494
Study Brief:
Protocol Section:
NCT06344494