Left atrial appendage closure with AtriLASH Seralene suture during cardiac surgery for atrial fibrillation

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

Adults with documented atrial fibrillation and elevated stroke risk who are already scheduled for cardiac surgery will have the left atrial appendage closed using the AtriLASH Seralene hemostatic suture during their operation. The study enrolls patients with CHA2DS2-VASc scores of 2 or greater and excludes those with LAA thrombus, unsuitable anatomy, active endocarditis, or very limited life expectancy. Outcomes will focus on perioperative safety and the effectiveness of achieving durable LAA closure to reduce thromboembolic events. Follow-up will monitor surgical complications, device performance, and stroke or bleeding outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Institute of cardiovascular diseases Vojvodina
  Kamenitz, Vojvodina, Serbia Recruiting

Study contacts

• Study coordinator: Lazar Velicki, MD, PhD
• Email: lazar.velicki@ikvbv.ns.ac.rs
• Phone: +381 21 4805701

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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.