Left Atrial Appendage Closure During Cardiac Surgery in Atrial Fibrillation Patients With Seralene

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Serbia
Institute of cardiovascular diseases Vojvodina
RECRUITING
Kamenitz
Contact Information
Primary
Lazar Velicki, MD, PhD
lazar.velicki@ikvbv.ns.ac.rs
+381 21 4805701
Backup
Milos Matkovic, MD,PhD
dr.matko@hotmail.com
Time Frame
Start Date: 2025-12-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 200
Treatments
Experimental: AF patients submitted to cardiac surgery
Participants in this arm are patients with atrial fibrillation undergoing cardiac surgery for a clinical indication and with a CHA₂DS₂-VASc score of 2 or greater. During the planned cardiac surgical procedure, surgical closure of the left atrial appendage is performed using the CE-marked AtriLASH suture-based device. The intervention is carried out as part of the same operative session and in addition to the indicated cardiac surgery. All participants receive the same intervention.
Related Therapeutic Areas
Sponsors
Leads: Institute of Cardiovascular Diseases, Vojvodina
Collaborators: KBC Rebro Zagreb, Clinical Centre of Serbia, Institute for Cardiovascular Diseases Dedinje

This content was sourced from clinicaltrials.gov