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:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-24 @ 5:47 PM
NCT ID:
NCT01628068
Eligibility Criteria:
Inclusion Criteria:
* documented atrial fibrilation (paroxysmal or permanent) without significant heart valve disease
* \> 18 years
* Classic oral anticoagulation(INR at therapeutic levels: 2-3) or New oral anticoagulants
* CHA2-DS2-VASC score ≥ 3
* prior digestive bleeding without any treatable cause
* Informed consent.
Exclusion Criteria:
* POF
* contraindication to further treatment with dual antiplatelet therapy (aspirin + clopidogrel)
* Intracardiac thrombus
* significant carotid disease
* Cardioversion scheduled within 30 days following the implantation
* AF not controlled by FVM\> 100 bpm
* AF secondary to surgery or ablation
* thrombosis in patients \<40 years
* chronic renal insufficiency with Cr clearance \<30 ml 2
* left appendage sizeappendage with inlet \<12.6 mm or \> 28.5 (ETE)
* depth of the appendage \<10mm in the TEE
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01628068
Study Brief:
Protocol Section:
NCT01628068