Anticoagulant Therapy, ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF), Mitral Valve Surgery, Stroke (in Patients With Atrial Fibrillation)
Conditions
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.
Interventions
DEVICELAA closure using the AtriLASH
The intervention consists of surgical closure of the left atrial appendage using the AtriLASH device during cardiac surgery. AtriLASH is a CE-marked, suture-based medical device made of Seralene material and is designed for epicardial closure of the left atrial appendage. The device is applied intraoperatively as part of the planned cardiac surgical procedure in patients with atrial fibrillation. The left atrial appendage is identified and closed using the AtriLASH system according to the manufacturer's instructions for use. No additional incisions or separate procedures are required beyond those necessary for the indicated cardiac surgery. The intervention is performed in all participants allocated to the study arm and is intended to achieve complete exclusion of the left atrial appendage to reduce the potential for blood stasis and thrombus formation.
Sponsors
Institute of Cardiovascular Diseases, Vojvodina
Institute for Cardiovascular Diseases Dedinje
KBC Rebro Zagreb
Clinical Centre of Serbia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left atrial appendage patency rate following closure | Three months after the LAA closure | To evaluate the patency rate of the left atrial appendage (LAA) following closure during cardiac surgery at the 3-month follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite incidence of stroke, systemic embolism, major bleeding, and all-cause mortality | Three months post-surgery | To assess the safety and efficacy of LAA closure during cardiac surgery in terms of: (1) Incidence of stroke or systemic embolism within 3 months post-surgery. (2) Major bleeding events within 3 months post-surgery. (3) All-cause mortality within 3 months post-surgery |
Countries
Serbia
Contacts
CONTACTLazar Velicki, MD, PhD
CONTACTMilos Matkovic, MD,PhD
Outcome results
None listed