NCT07360899 Atrial Fibrillation TRIal of Left Atrial Appendage Closure Using Seralene Hemostatic Suture
| NCT ID | NCT07360899 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institute of Cardiovascular Diseases, Vojvodina |
| Condition | ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2026-04-30 |
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.
This trial targets 200 participants in total. It began in 2025-12-01 with a primary completion date of 2026-04-30.
⚠ 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
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 surgical closure of the left atrial appendage using a device called AtriLASH during cardiac surgery. AtriLASH is a surgical suture-based device intended to close the left atrial appendage. The study will assess whether the left atrial appendage can be safely and effectively closed using this method in patients with atrial fibrillation undergoing cardiac surgery. The information obtained from this study may help determine whether this approach can reduce the risk of stroke and potentially decrease the need for long-term use of blood-thinning medications in selected patients.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07360899 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07360899 currently recruiting?
Yes, NCT07360899 is actively recruiting participants. Contact the research team at lazar.velicki@ikvbv.ns.ac.rs for enrollment information.
Where is the NCT07360899 trial being conducted?
This trial is being conducted at Kamenitz, Serbia.
Who is sponsoring the NCT07360899 clinical trial?
NCT07360899 is sponsored by Institute of Cardiovascular Diseases, Vojvodina. The trial plans to enroll 200 participants.
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