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 @ 4:50 AM
Ignite Modification Date:
2025-12-25 @ 4:50 AM
NCT ID:
NCT06969118
Eligibility Criteria:
Inclusion Criteria:
1. Age 18 - 85 years old, all genders;
2. Subjects who can understand the purpose of the trial, participate voluntarily and sign the informed consent form, and are willing to complete the follow-up according to the protocol requirements;
3. Indications for left atrial appendage closure: non-valvular atrial fibrillation patients with CHA2DS2-VAS2 score ≥2 and HAS-BLED score ≥3, or who are unable or unwilling to receive long-term oral anticoagulants;
4. Life expectancy ≥1 year;
Exclusion Criteria:
1. Preoperative TEE/heart CT/intracardiac ultrasound suggested thrombus in the left atrial appendage/left atrium;
2. Patients with severe renal insufficiency (creatinine ≥200 μmol/L, creatinine clearance \<30 ml/min);
3. Liver disease patients with coagulation abnormalities and clinically relevant bleeding risks, including liver cirrhosis patients reaching Child Pugh stages B and C;
4. Severely decreased platelet count at baseline: PLT ≤50\*10\^9/L;
5. Patients with severe preoperative cardiac insufficiency (LVEF \<35%; clinical manifestations are uncontrolled class IV heart failure);
6. Combined with other severe cardiac valvular diseases or other structural abnormalities that require surgical treatment on an elective day; or severe coronary heart disease that requires intervention within a fixed period;
7. Patients who have lesions or conditions with a significant risk of major bleeding, such as current or recent gastrointestinal ulcers, malignant tumors with a high risk of bleeding, recent brain or spinal injuries, recent brain, spinal or ophthalmic procedure, recent intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms, or major intraspinal or intracerebral vascular malformations;
8. Patients with concurrent diseases (other than atrial fibrillation) that require anticoagulant therapy (such as after mechanical valve replacement, and spontaneous or recurrent venous thromboembolism);
9. Patients who are in clinical trials of other drugs or medical devices and have not completed it yet;
10. Patients who are considered ineligible to participate in the clinical trial by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT06969118
Study Brief:
Protocol Section:
NCT06969118