Actively Recruiting
Optimal Antiplatelet Therapy Following Left Atrial Appendage Closure in Dialyzed Patients
Led by National Institute of Cardiology, Warsaw, Poland · Updated on 2024-06-25
80
Participants Needed
1
Research Sites
191 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 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
CONDITIONS
Official Title
Optimal Antiplatelet Therapy Following Left Atrial Appendage Closure in Dialyzed Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Need for dual antiplatelet therapy other than for left atrial appendage occlusion at enrollment or expected during the trial (e.g., planned coronary revascularization)
- Need for anticoagulation at enrollment or expected during the trial (e.g., pulmonary embolism), excluding anticoagulation used during dialysis
- Known allergy to clopidogrel and/or acetylsalicylic acid
- Peridevice leak greater than 5 mm on imaging before enrollment
- Left atrial thrombus seen after successful left atrial appendage closure but before enrollment
- Life expectancy less than 18 months
- Participation in other clinical studies with experimental therapies at enrollment or within the past 3 months
- Women who are pregnant, breastfeeding, or of childbearing potential not agreeing to use at least two contraception methods (except women 2 years post-menopause with negative pregnancy test if under 55, or after surgical sterilization)
AI-Screening
AI-Powered Screening
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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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