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ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATIONATRI-LASHNCT07360899

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

A study testing LAA closure using the AtriLASH in people with ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION and Atrial Fibrillation (AF), run by Institute of Cardiovascular Diseases, Vojvodina at 1 site in Serbia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
LAA closure using the AtriLASH
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteSerbia
Study dates
1 Dec 2025to 30 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lazar Velicki, MD, PhD contact

+381 21 4805701

lazar.velicki@ikvbv.ns.ac.rs

Milos Matkovic, MD,PhD contact

dr.matko@hotmail.com

Serbia1 site, 1 recruiting
  • Institute of cardiovascular diseases Vojvodina

    Kamenitz, Vojvodina, 21204

    Lazar Velicki, +381 21 4805701, lazar.velicki@ikvbv.ns.ac.rs

    Recruiting

Other trials in Serbia

About this study

Official title: 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.

Read more

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.

Being tested
LAA closure using the AtriLASH
Medical subject headings
Atrial Fibrillation, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LAA closure using the AtriLASHDevice

    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.

Study groups in NCT07360899
Study groupRoleWhat they receive
AF patients submitted to cardiac surgeryExperimentalParticipants 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.
Receives: Device: LAA closure using the AtriLASH

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Left atrial appendage patency rate following closure

    To evaluate the patency rate of the left atrial appendage (LAA) following closure during cardiac surgery at the 3-month follow-up.

    Measured: Three months after the LAA closure

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

    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

    Measured: Three months post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2026
  2. Study start1 Dec 2025
  3. Primary completion30 Apr 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07360899
Sponsor's protocol ID
1351-1/7
Acronym
ATRI-LASH
Status last verified
Jan 2026
First submitted
6 Jan 2026
Last updated
22 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Joglar JA, Chung MK, Armbruster AL, Benjamin EJ, Chyou JY, Cronin EM, Deswal A, Eckhardt LL, Goldberger ZD, Gopinathannair R, Gorenek B, Hess PL, Hlatky M, Hogan G, Ibeh C, Indik JH, Kido K, Kusumoto F, Link MS, Linta KT, Marcus GM, McCarthy PM, Patel N, Patton KK, Perez MV, Piccini JP, Russo AM, Sanders P, Streur MM, Thomas KL, Times S, Tisdale JE, Valente AM, Van Wagoner DR; Peer Review Committee Members. 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2024 Jan 2;149(1):e1-e156. doi: 10.1161/CIR.0000000000001193. Epub 2023 Nov 30.

    PubMed 38033089
  • Tzikas A, Holmes DR Jr, Gafoor S, Ruiz CE, Blomstrom-Lundqvist C, Diener HC, Cappato R, Kar S, Lee RJ, Byrne RA, Ibrahim R, Lakkireddy D, Soliman OI, Nabauer M, Schneider S, Brachmann J, Saver JL, Tiemann K, Sievert H, Camm AJ, Lewalter T. Percutaneous left atrial appendage occlusion: the Munich consensus document on definitions, endpoints, and data collection requirements for clinical studies. Europace. 2017 Jan;19(1):4-15. doi: 10.1093/europace/euw141. Epub 2016 Aug 18.

    PubMed 27540038
  • De Caterina R, Camm AJ. What is 'valvular' atrial fibrillation? A reappraisal. Eur Heart J. 2014 Dec 14;35(47):3328-35. doi: 10.1093/eurheartj/ehu352. Epub 2014 Sep 28. No abstract available.

    PubMed 25265975
  • Ostermayer SH, Reisman M, Kramer PH, Matthews RV, Gray WA, Block PC, Omran H, Bartorelli AL, Della Bella P, Di Mario C, Pappone C, Casale PN, Moses JW, Poppas A, Williams DO, Meier B, Skanes A, Teirstein PS, Lesh MD, Nakai T, Bayard Y, Billinger K, Trepels T, Krumsdorf U, Sievert H. Percutaneous left atrial appendage transcatheter occlusion (PLAATO system) to prevent stroke in high-risk patients with non-rheumatic atrial fibrillation: results from the international multi-center feasibility trials. J Am Coll Cardiol. 2005 Jul 5;46(1):9-14. doi: 10.1016/j.jacc.2005.03.042.

    PubMed 15992628
  • Massumi A, Chelu MG, Nazeri A, May SA, Afshar-Kharaghan H, Saeed M, Razavi M, Rasekh A. Initial experience with a novel percutaneous left atrial appendage exclusion device in patients with atrial fibrillation, increased stroke risk, and contraindications to anticoagulation. Am J Cardiol. 2013 Mar 15;111(6):869-73. doi: 10.1016/j.amjcard.2012.11.061. Epub 2013 Jan 9.

    PubMed 23312129
  • Boersma LV, Schmidt B, Betts TR, Sievert H, Tamburino C, Teiger E, Pokushalov E, Kische S, Schmitz T, Stein KM, Bergmann MW; EWOLUTION investigators. Implant success and safety of left atrial appendage closure with the WATCHMAN device: peri-procedural outcomes from the EWOLUTION registry. Eur Heart J. 2016 Aug;37(31):2465-74. doi: 10.1093/eurheartj/ehv730. Epub 2016 Jan 27.

    PubMed 26822918
  • Holmes DR Jr, Kar S, Price MJ, Whisenant B, Sievert H, Doshi SK, Huber K, Reddy VY. Prospective randomized evaluation of the Watchman Left Atrial Appendage Closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol. 2014 Jul 8;64(1):1-12. doi: 10.1016/j.jacc.2014.04.029.

    PubMed 24998121
  • Reddy VY, Doshi SK, Sievert H, Buchbinder M, Neuzil P, Huber K, Halperin JL, Holmes D; PROTECT AF Investigators. Percutaneous left atrial appendage closure for stroke prophylaxis in patients with atrial fibrillation: 2.3-Year Follow-up of the PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation) Trial. Circulation. 2013 Feb 12;127(6):720-9. doi: 10.1161/CIRCULATIONAHA.112.114389. Epub 2013 Jan 16.

    PubMed 23325525
  • Whitlock RP, Vincent J, Blackall MH, Hirsh J, Fremes S, Novick R, Devereaux PJ, Teoh K, Lamy A, Connolly SJ, Yusuf S, Carrier M, Healey JS. Left Atrial Appendage Occlusion Study II (LAAOS II). Can J Cardiol. 2013 Nov;29(11):1443-7. doi: 10.1016/j.cjca.2013.06.015. Epub 2013 Sep 20.

    PubMed 24054920

Questions about this trial

What is this clinical trial studying?

A study testing LAA closure using the AtriLASH in people with ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION and Atrial Fibrillation (AF), run by Institute of Cardiovascular Diseases, Vojvodina at 1 site in Serbia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lazar Velicki, MD, PhD (+381 21 4805701, lazar.velicki@ikvbv.ns.ac.rs), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Left atrial appendage patency rate following closure (time frame: Three months after the LAA closure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07360899, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.

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