SAFE-LAAC CKD Trial has been designed to gather data on the most optimal strategy of antiplatelet therapy after transcatheter left atrial appendage occlusion with Amplatzer or WATCHMAN device in patients with the end-stage renal disease treated with chronic haemodialysis or peritoneal dialysis
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
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
National Institute of Cardiology, Warsaw, Poland
Lead sponsor
Medical Research Agency, Poland
Collaborator