NCT03445949 Optimal Antiplatelet Therapy Following Left Atrial Appendage Closure
| NCT ID | NCT03445949 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | National Institute of Cardiology, Warsaw, Poland |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2018-01-23 |
| Primary Completion | 2025-06-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 200 participants in total. It began in 2018-01-23 with a primary completion date of 2025-06-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Contact & Investigator
Radoslaw Pracon, MD PhD
PRINCIPAL INVESTIGATOR
Coronary and Structural Heart Diseases Department, National Institute of Cardiology, Warsaw, Poland
Frequently Asked Questions
Who can join the NCT03445949 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03445949 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03445949 currently recruiting?
Yes, NCT03445949 is actively recruiting participants. Contact the research team at rpracon@ikard.pl for enrollment information.
Where is the NCT03445949 trial being conducted?
This trial is being conducted at Warsaw, Poland.
Who is sponsoring the NCT03445949 clinical trial?
NCT03445949 is sponsored by National Institute of Cardiology, Warsaw, Poland. The principal investigator is Radoslaw Pracon, MD PhD at Coronary and Structural Heart Diseases Department, National Institute of Cardiology, Warsaw, Poland. The trial plans to enroll 200 participants.
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