Left Atrial Appendage Occlusion vs. Usual Care in Patients With Atrial Fibrillation and Severe Ch… (NCT02039167) | Clinical Trial Compass
TerminatedNot Applicable
Left Atrial Appendage Occlusion vs. Usual Care in Patients With Atrial Fibrillation and Severe Chronic Kidney Disease
Stopped: The recruitment rate was very poor. The study was stopped by amendment on 2015-08-28.
Germany14 participantsStarted 2014-01
Plain-language summary
The purpose of this study is to evaluate the superiority of left atrial appendage occlusion in comparison to oral anticoagulation with a vitamin K antagonist (INR 2-3) related to the frequency of occurrence of at least one bleeding classified as moderate or major within 24 months.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF), documented by electrocardiography performed at screening or within the prior 6 months
* Indication for oral anticoagulation as assessed by CHA2DS2-VASc-Score (≥ 2)
* Severe to end-stage chronic kidney disease (eGFR \< 30 ml/min as determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula)
* 18 to 80 years, inclusive
* Life expectancy of at least 2 years
* Negative pregnancy test for women
* Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
* Written informed consent
Exclusion Criteria:
* AF due to a reversible cause or a singular occurrence of AF
* Conditions other than AF that require anticoagulation
* Transient ischemic attack or stroke within previous 3 months
* A need for Aspirin (at a dose of \> 162.5 mg/day) or for both Aspirin and Clopidogrel/other antiplatelet drugs (daily administration) other than for clinical investigation
* Contraindications or allergies to vitamin K antagonists, Aspirin or Clopidogrel
* Previous closure (surgical, interventional) of the left atrial appendage (LAA)
* Previous closure of atrial septal defect (ASD) / persistent foramen ovale (PFO)
* Active internal bleeding
* Thrombocytopenia (\< 100,000 platelets/mm3)
* History of or planned organ transplantation
* Planned Mitra Clip or transcatheter aortic valve implantation (TAVI) i…
What they're measuring
1
Frequency of occurrence of moderate and major bleedings (Type 2 to Type 5 according to the Bleeding Academic Research Consortium (BARC) definitions)