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 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT03446794
Eligibility Criteria:
Inclusion Criteria:
* Age\> 18 years.
* Stage V chronic kidney disease (GFR \<15 ml / min) in hemodialysis at the time of left atrial appendage closure.
* History of atrial or valvular fibrillation (paroxysmal, persistent, permanent).
* Less moderate embolic risk (CHA2DS2-VASc ≥2) or active oral anticoagulant therapy due to atrial fibrillation.
* High associated hemorrhagic risk (HASBLED ≥ 3) or a history of major bleeding (BARC\> 2).
* The patient has been informed of the characteristics of the study and has provided written informed consent.
Exclusion Criteria:
* Life expectancy \< 2 years.
* Indication for OA different from NVAF.
* Severe pericardial effusion.
* Previous percutaneous closure of atrial septal defect.
* Intracardiac thrombus.
* Severe hepatic dysfunction with spontaneous INR (International Normalized Ratio) \> 1.5.
* The patient refuses to participate in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03446794
Study Brief:
Protocol Section:
NCT03446794