Optimal Antiplatelet Therapy Following Left Atrial Appendage Closure in Dialyzed Patients (SAFE LAAC CKD)
Atrial Fibrillation
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring atrial fibrillation, stroke, bleeding, left atrial appendage, dialysis
Eligibility Criteria
Inclusion Criteria: Successful left atrial appendage occlusion with Amplatzer or WATCHMAN device within 37 days prior to randomization End-stage renal disease treated with chronic haemodialysis or peritoneal dialysis Participant's age 18 years or older at the time of signing the informed consent form Participant is willing to follow all study procedures; especially the randomized antiplatelet treatment regimen Participant is willing to sign the study informed consent form Exclusion Criteria: Indications to dual antiplatelet therapy other than left atrial appendage occlusion at the time of enrollment and/or predicted appearance of such indications within the duration of the trial (e.g. planned coronary revascularization) Indications to anticoagulation at the time of enrollment and/or predicted appearance of such indications within the duration of the trial (e.g. pulmonary embolism). Does not apply to anticoagulation used during dialysis Known allergy to clopidogrel and/or acetylsalicylic acid precluding its administration as specified by the protocol Peridevice leak >5mm on imaging study preceding enrollment Left atrial thrombus on an imaging study performed after successful left atrial appendage closure but before enrollment Life expectancy of fewer than 18 months Participation in other clinical studies with experimental therapies at the time of enrollment and/or preceding 3 months Women who are pregnant or breastfeeding; women of childbearing potential who do not consent to apply at least two methods of contraception. This criterion does not apply to women 2 years post menopause (with a negative pregnancy test 24 hours before randomization if <55 years old) or after surgical sterilization
Sites / Locations
- National Institute of CardiologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Other
Other
Other
Other
30 days DAPT and long-term treatment with a single antiplatelet agent
6 months DAPT and long-term treatment with a single antiplatelet agent
30 days DAPT and 6 months treatment with a single antiplatelet agent
6 months DAPT and 6 months treatment with a single antiplatelet agent
short postimplantation dual antiplatelet therapy and long-term treatment with a single antiplatelet agent
extended postimplantation dual antiplatelet therapy and long-term treatment with a single antiplatelet agent
short postimplantation dual antiplatelet therapy and 6 months treatment with a single antiplatelet agent
extended postimplantation dual antiplatelet therapy and 6 months treatment with a single antiplatelet agent