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 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT05144958
Eligibility Criteria:
Inclusion Criteria:
1. patients aged ≥18 years;
2. ECG/Holter diagnosis of AF;
3. Previous stroke or systemic thromboembolic complications;
4. High risk of thromboembolic complications - CHA2DS2-VASc Score ≥ 2;
5. HASBLED score of \> 2;
6. Contraindications to oral anticoagulation or Complications of oral anticoagulation;
(8) Acceptable surgical candidate, including use of general anesthesia; (9) patient adherence to the study and patient Informed Consent Form has been signed
Exclusion Criteria:
1. No ECG with AF recorded (12-lead ECG, Holter recording, external event recorder or implantable loop recorder) or only atrial flutter recorded,
2. Significant valve disease or coronary multivessel artery lesions requiring operation;
3. Stroke/cerebrovascular accident (CVA) within previous 30 days;
4. Critical preoperative state;
5. participation in a clinical trial
6. patient refusal
Registry imposes intraoperative exclusion criteria to otherwise enrolled patients:
1. Presence of thrombus in the LA or LAA
2. LAA tissue with significant adhesions (as evaluated by the surgeon) making AtriClip® placement overly risky.
3. Previous cardiac operations (e.g., CABG, heart transplant, valvular replacement) making LARIAT placement overly risky.
4. Patients with a previous atrial septal defect with surgical or transcatheter closure making Watchman placement overly risky.
5. NYHA IV;
6. Right-sided heart failure;
7. Symptomatic carotid artery disease;
8. active systemic infection.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05144958
Study Brief:
Protocol Section:
NCT05144958