Status:
RECRUITING
Optimal Antiplatelet Therapy Following Left Atrial Appendage Closure
Lead Sponsor:
National Institute of Cardiology, Warsaw, Poland
Collaborating Sponsors:
Medical Research Agency, Poland
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
SAFE-LAAC 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
Detailed Description
Background: Transcatheter left atrial appendage closure (LAAC) has been shown to be non-inferior to oral anticoagulation in preventing cardioembolic strokes associated with atrial fibrillation. Howev...
Eligibility Criteria
Inclusion
- Successful left atrial appendage occlusion with Amplatzer or WATCHMAN device within 37 days before randomization
- Treatment with dual antiplatelet therapy (clopidogrel and acetylsalicylic acid) between left atrial appendage closure and randomization
- 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
- Indications to dual antiplatelet therapy other than atrial fibrillation and/or left atrial appendage occlusion at the time of enrollment 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)
- Known allergy to clopidogrel and/or acetylsalicylic acid precluding its administration as specified by the protocol
- Any known inborn or acquired coagulation disorders
- 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 preceding 3 months
- Chronic kidney disease stage IV and V
- 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 negative pregnancy test 24 hours prior to randomization if \<55 years old) or after surgical sterilization
Key Trial Info
Start Date :
January 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 23 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03445949
Start Date
January 23 2018
End Date
June 23 2027
Last Update
July 11 2023
Active Locations (1)
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1
National Institute of Cardiology
Warsaw, Masovian Voivodeship, Poland, 04-628