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

January 14, 2026 updated by: Lazar Velicki, Institute of Cardiovascular Diseases, Vojvodina

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Serbia
    • Vojvodina
      • Kamenitz, Vojvodina, Serbia, 21204
        • Recruiting
        • Institute of Cardiovascular Diseases Vojvodina
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: LAA 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Three months after the LAA closure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Three months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Cardiovascular Diseases, Vojvodina

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1351-1/7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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