Left atrial appendage closure with AtriLASH Seralene suture during cardiac surgery for atrial fibrillation
Left Atrial Appendage Closure During Cardiac Surgery in Atrial Fibrillation Patients With Seralene
This trial tests whether closing the left atrial appendage with the AtriLASH Seralene hemostatic suture during cardiac surgery can reduce stroke risk in adults with atrial fibrillation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute of Cardiovascular Diseases, Vojvodina Academic / other |
| Locations | 1 site (Kamenitz, Vojvodina) |
| Trial ID | NCT07360899 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (18+) with any type of atrial fibrillation, a CHA2DS2-VASc score ≥2, and who are scheduled for cardiac surgery are ideal candidates.
Not a fit: Patients with left atrial appendage thrombus, anatomies unsuitable for the device, active infective endocarditis, or very limited life expectancy are unlikely to benefit from this procedure.
Why it matters
Potential benefit: If successful, this approach could lower stroke risk for surgical patients with atrial fibrillation and offer an option for those who cannot take long-term blood thinners.
How similar studies have performed: Surgical left atrial appendage closure has prior supportive data with other techniques, but use of the AtriLASH Seralene hemostatic suture is relatively novel and not yet widely tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Kamenitz, Vojvodina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.