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Atrial Fibrillation TRIal of Left Atrial Appendage Closure Using Seralene Hemostatic Suture

RecruitingNAAges 18 Years - anyAllInstitute of Cardiovascular Diseases, Vojvodina
NCT07360899 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Atrial fibrillation is a common heart rhythm disorder that increases the risk of stroke. In patients with atrial fibrillation, blood clots most often form in a small structure of the heart called the left atrial appendage. If a blood clot travels from the heart to the brain, it can cause a stroke. Blood-thinning medications are commonly prescribed to reduce the risk of stroke in patients with atrial fibrillation. However, some patients cannot take these medications long-term because of bleeding risk, side effects, or other medical reasons. Closing the left atrial appendage is an alternative approach to reduce the risk of stroke by preventing blood from collecting in this area. When patients undergo cardiac surgery for another indication, closure of the left atrial appendage can be performed during the same operation. This study is designed to evaluate the safety and effectiveness of s

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📋 Eligibility rules (as published)
Inclusion Criteria: Age 18 years or older Documented atrial fibrillation (any type) CHA₂DS₂-VASc score of 2 or greater, or equivalent stroke risk Scheduled to undergo cardiac surgery (including coronary artery bypass grafting, valve surgery, or other structural cardiac surgery) Ability to understand the study and provide written informed consent Exclusion Criteria: Contraindication to left atrial appendage closure (e.g., presence of left atrial appendage thrombus or unsuitable anatomy) Life expectancy less than 3 months, based on clinical judgment Current participation in another clinical study that could interfere with the outcomes of this study Active or suspected infective endocarditis
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What it tests

  • LAA closure using the AtriLASH
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Where

1 site
Institute of cardiovascular diseases Vojvodina
Kamenitz, Serbia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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