Optimal Antiplatelet Therapy Following Left Atrial Appendage Closure
Recruiting · NCT03445949 · Interventional (participants receive a specific treatment) · Lead sponsor: National Institute of Cardiology, Warsaw, Poland
View the official record on ClinicalTrials.gov →Interventions studied
6 months treatment with a single antiplatelet agentextended postimplantation dual antiplatelet therapylong-term treatment with a single antiplatelet agentshort postimplantation dual antiplatelet therapy
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed.
- National Institute of Cardiology - Warsaw, Masovian Voivodeship, Poland