Optimal antiplatelet therapy after left atrial appendage closure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The SAFE-LAAC Trial aims to determine the best antiplatelet therapy strategy following transcatheter left atrial appendage closure using the Amplatzer or WATCHMAN device. This multicenter, open-label trial will compare the safety and efficacy of two durations of dual antiplatelet therapy (30 days vs. 6 months) and evaluate the outcomes of stopping all antithrombotic agents after 6 months versus continuing with a single antiplatelet agent. The study will involve 200 patients who have successfully undergone left atrial appendage closure. The results will inform clinical guidelines and future research on optimal antithrombotic treatment post-procedure.

Why it matters

Who can join: the full rules

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's running

• National Institute of Cardiology
  Warsaw, Masovian Voivodeship, Poland Recruiting

Study contacts

• Principal investigator: Radoslaw Pracon, MD PhD — Coronary and Structural Heart Diseases Department, National Institute of Cardiology, Warsaw, Poland
• Study coordinator: Radoslaw Pracon, MD PhD
• Email: rpracon@ikard.pl
• Phone: 22 343 43 42

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals

  This study tests AI-powered tools on real-world stroke patients to see if they can improve pre-hospital triage, diagnosis, and outcome prediction while data stay securely within each hospital.

  Recruiting at 2 sites Hospital Universitari Vall d'Hebron Research Institute · Leuven and 6 other locations · NCT07924371

• Left-atrial Fibrosis in Persistent Atrial Fibrillation and Its Comorbidities

  This study tests how comorbid conditions like sleep apnea and primary aldosteronism relate to left-atrial fibrosis and AF recurrence in patients undergoing ablation.

  Recruiting University Hospital Augsburg · Augsburg, Bavaria · NCT07857044

• Dual Energy ablation with SmartTouch SF catheter in persistent atrial fibrillation

  This study tests a pulsed field and radiofrequency ablation system to treat persistent atrial fibrillation in adults who have not responded well to prior medications.

  Recruiting at 4 sites Biosense Webster, Inc. · Beijing and 3 other locations · NCT07845682

• Identifying AF patients who may need more than standard ablation using Volta AF-Xplorer II

  This trial tests whether AI-identified dispersion areas during AF ablation can predict recurrence after a standard pulmonary vein isolation in patients with persistent AF.

  Recruiting Volta Medical · Avignon and 4 other locations · NCT07807423

• 4D intracardiac echocardiography to guide left atrial appendage occlusion procedures

  A new 4D ICE catheter is being tested alongside standard imaging to see if it can safely guide left atrial appendage occlusion procedures for adults with atrial fibrillation.

  Recruiting The Cleveland Clinic · Cleveland, Ohio · NCT07806890

• Thoracoscopic vs Catheter Ablation as the First Rhythm Control in Atrial Fibrillation with a Large Left Atrium

  This trial tests whether thoracoscopic surgical ablation is better at keeping atrial fibrillation under control than catheter ablation in people with persistent AF and a large left atrium who have not had an ablation before.

  Recruiting Samsung Medical Center · Seoul, Seoul · NCT07783984

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.