Actively Recruiting
Optimal Antiplatelet Therapy Following Left Atrial Appendage Closure
Led by National Institute of Cardiology, Warsaw, Poland · Updated on 2023-07-11
200
Participants Needed
1
Research Sites
491 weeks
Total Duration
On this page
Sponsors
N
National Institute of Cardiology, Warsaw, Poland
Lead Sponsor
M
Medical Research Agency, Poland
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Optimal Antiplatelet Therapy Following Left Atrial Appendage Closure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
- Indications to anticoagulation at the time of enrollment and/or predicted appearance of such indications within the duration of the trial
- Known allergy to clopidogrel and/or acetylsalicylic acid precluding its administration
- Any known inborn or acquired coagulation disorders
- Peridevice leak greater than 5mm on imaging study before enrollment
- Left atrial thrombus on imaging after successful closure but before enrollment
- Life expectancy fewer than 18 months
- Participation in other clinical studies with experimental therapies within 3 months before enrollment
- Chronic kidney disease stage IV and V
- Women who are pregnant or breastfeeding; women of childbearing potential who do not consent to use at least two contraception methods (except women 2 years post menopause or surgically sterile)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institute of Cardiology
Warsaw, Masovian Voivodeship, Poland, 04-628
Actively Recruiting
Research Team
R
Radoslaw Pracon, MD PhD
CONTACT
M
Marcin Demkow, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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