Atrial Fibrillation TRIal of Left Atrial Appendage Closure Using Seralene Hemostatic Suture (ATRI-LASH)

Institute of Cardiovascular Diseases, Vojvodina

Status: Enrolling

Conditions: Stroke (in Patients With Atrial Fibrillation); ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION; Atrial Fibrillation (AF); Mitral Valve Surgery; Anticoagulant Therapy

Treatments: Device: LAA closure using the AtriLASH

Study type: Interventional

Funder types: Other

Identifiers

NCT07360899

1351-1/7

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

200 participants in 1 patient group

AF patients submitted to cardiac surgery

Experimental group

Description:

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.

Treatment:

Device: LAA closure using the AtriLASH