Optimal Antiplatelet Therapy Following Left Atrial Appendage Closure in Dialyzed Patients

• Status: Recruiting
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Cardiology, Warsaw, Poland
• Collaborator: Medical Research Agency, Poland
• Treatments: Platelet Aggregation Inhibitors

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