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NCT Number: NCT07360899

Atrial Fibrillation TRIal of Left Atrial Appendage Closure Using Seralene Hemostatic Suture

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of cardiovascular diseases Vojvodina

Kamenitz, Vojvodina, 21204, Serbia

Location status: Recruiting

Location contact

Lazar Velicki

CONTACT

[email protected]

+381 21 4805701

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LAA closure using the AtriLASH

Device

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.

Primary outcomes

  1. Left atrial appendage patency rate following closure

    Time frame: 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 outcomes

  1. Composite incidence of stroke, systemic embolism, major bleeding, and all-cause mortality

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Lazar Velicki, MD, PhD

CONTACT

[email protected]

+381 21 4805701

Milos Matkovic, MD,PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Institute of Cardiovascular Diseases, Vojvodina

Other

Collaborators

  • Clinical Centre of Serbia
  • Institute for Cardiovascular Diseases Dedinje
  • KBC Rebro Zagreb

Registry information

Official study title

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

Acronym: ATRI-LASH

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2026
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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