Atrial Fibrillation
Conditions
Brief summary
Primary endpoint: comprising major adverse cardiac and cerebrovascular events defined as: 1. efficacy: MACCE - stroke, TIA, peripheral embolism, nonfatal myocardial infarction, cardiovascular and overall mortality; device related thrombosis; and 2. safety: moderate and severe bleedings (type 2-5 BARC).
Detailed description
individual components of the composite primary end point and: 1. any bleeding 2. new intermediate and large ischemic lesions (≥4mm in size) in central nervous system as assessed by brain MRI 3. new cognitive disorders as assessed by Addenbrooke's Cognitive Examination (ACE-III) 4. thrombosis of the dialysis access; 5. efficacy and safety of LAAC in the periprocedural and 1 month followup
Interventions
DRUGACETYLSALICYLIC ACID
DRUGCLOPIDOGREL
Sponsors
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: comprising major adverse cardiac and cerebrovascular events defined as: 1. efficacy: MACCE - stroke, TIA, peripheral embolism, nonfatal myocardial infarction, cardiovascular and overall mortality; device related thrombosis; and 2. safety: moderate and severe bleedings (type 2-5 BARC). | — |
Secondary
| Measure | Time frame |
|---|---|
| individual components of the composite primary end point and: 1. any bleeding 2. new intermediate and large ischemic lesions (≥4mm in size) in central nervous system as assessed by brain MRI 3. new cognitive disorders as assessed by Addenbrooke's Cognitive Examination (ACE-III) 4. thrombosis of the dialysis access; 5. efficacy and safety of LAAC in the periprocedural and 1 month followup | — |
Countries
Poland
Outcome results
None listed