ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATIONSTELLA-AFNCT07705282
Standalone Thoracoscopic Left Atrial Appendage Closure Versus Medical Therapy in Atrial Fibrillation
A study testing Video-assisted thoracoscopic closure of the left atrial appendage using a closure device and discontinuation of treatment if the patient is treated with OAC in people with ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION and Oral Anticoagulation, run by Region Skane at 1 site in Sweden.
Trial summary
Surgical left atrial appendage closure (LAAC) has been associated with reduced rates of stroke in patients with atrial fibrillation (AF) who have undergone cardiac surgery. In recent time, procedures with catheter-based devices for LAAC have failed to achieve results that would make them considered a safe alternative… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Oral Anticoagulation, Thoracotomy
- What is being tested?
- Video-assisted thoracoscopic closure of the left atrial appendage using a closure device and discontinuation of treatment if the patient is treated with OAC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 936 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2028to 31 Dec 2032
- Phase
- Interventional
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 and any of criteria 2-3
- AF with a CHA2DS2-VA score ≥2 and a HAS-BLED score ≥3 or other clinically significant bleeding condition and ongoing OAC treatment
- AF with a CHA2DS2-VA score ≥2 but deemed unfit for OAC by responsible physician due to clinical contraindications (e.g. amyloid angiopathy, previous intracranial haemorrhage or severe gastrointestinal bleeding).
Who cannot join
- Clinical frailty score ≥5
- Indication for OAC other than AF
- Indication for dual antiplatelet therapy, if OAC is discontinued
- Previous open-heart surgery
- Present indication for cardiac surgery
- Present indication for ablation for atrial fibrillation
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- Previous radiation therapy of the chest, due to malignancy
- Previous pericarditis or myocarditis
- Previous surgery including access to the left pleural space
- Documented FEV1<70% or other significant pulmonary disease (including but not restricted to fibrosis, pulmonary post-covid syndrome, cystic fibrosis)
- Ongoing treatment with corticosteroids or previous treatment for more than 3 consecutive months.
- Allergy to contrast media
- Patient already included in another interventional clinical trial
- Patient listed abroad, which would render them to be lost to follow-up after discharge
- Patient does not understand study information given in the local language or, for other reasons, is deemed unfit to participate according to the investigators
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Skånes universitetssjukhus
Lund
Igor Zindovic, +4646173300, igor.zindovic@skane.se
About this study
Surgical left atrial appendage closure (LAAC) has been associated with reduced rates of stroke in patients with atrial fibrillation (AF) who have undergone cardiac surgery. In recent time, procedures with catheter-based devices for LAAC have failed to achieve results that would make them considered a safe alternative to oral anticoagulation. Several concerns regarding catheter-based devices have been raised due to their contact with circulating blood, device migration and periprocedural complications. LAAC using an externally placed clip via thoracoscopy would elude some of these concerns and may therefore be a feasible alternative to oral anticoagulation in patients with AF.
This study aims to assess whether thoracoscopic left atrial appendage closure (TLAAC) is noninferior to medical treatment in patients with AF and an elevated bleeding risk using or being planned to initiate OAC and in those patients with clinical contraindications to oral anticoagulants.
Read the detailed description
Atrial fibrillation (AF) is the most common sustained arrhythmia worldwide and is associated with a markedly increased risk of ischemic stroke, heart failure, cognitive decline, systemic embolism, hospitalization, and mortality. AF-related strokes are often severe, disabling, and recurrent. Based on extrapolation of published regional Swedish data, 350-400 000 individuals in Sweden have atrial fibrillation, of whom 81% are treated with OAC:s. Despite major advances in anticoagulation, AF continues to represent one of the most important cardiovascular contributors to long-term disability and healthcare expenditure.
For decades, oral anticoagulation with vitamin K antagonists represented the cornerstone of stroke prevention. The introduction of direct anticoagulant (DOAC) treatment fundamentally altered the therapeutic landscape. Trials including RE-LY, ROCKET-AF and ARISTOTLE demonstrated that DOAC therapy provides excellent protection against stroke/systemic embolism while reducing intracranial hemorrhage compared with warfarin. Consequently, DOACs became the standard of care for most patients with nonvalvular AF and are supported as first line treatment for most patients with nonvalvular AF.
However, anticoagulation is not without its downsides. Despite modern OACs, treatment poses a significant bleeding risk and a lifelong treatment burden. Clinical decision making is complicated by patient frailty, renal dysfunction, liver disease and by patients with previous history of intracranial or gastrointestinal bleeding. Furthermore, long-term adherence is imperfect in real-world practice. In above mentioned trials, the annual bleeding risk ranged from 2.1-3.6% in patients treated with OAC, corresponding to 8400-14400 Swedish patients having major bleeding events from AF-related OAC treatment each year.
Long-term anticoagulation may be associated with treatment burden, fear of bleeding, reduced treatment satisfaction, and impaired quality of life in some patients. Thus, the concept of a nonpharmacological strategy to prevent stroke remains highly attractive.
Left atrial appendage closure While initial trials showed promising results of catheter based endocardial LAAC in the Warfarin era, the CLOSURE-AF trial recently showed that that endocardial devices, including the WATCHMAN™ and the Amplatzer™ Amulet™, do not achieve results making them a feasible replacement for modern OAC therapy in AF patients with elevated bleeding risk. The limitations of endocardial LAAC have several explanations. Implantation of a foreign body within the left atrium creates a potential substrate for thrombus formation. Device-related thrombi have been associated with increased risk of ischemic stroke and remain a recognized complication of endocardial LAAC. Incomplete sealing may allow persistent blood flow into the appendage, potentially preserving thromboembolic risk. In addition, many patients require OAC or dual antiplatelet therapy during the endothelialisation period. Procedure related risks include vascular complications, procedure-related stroke, device embolization and pericardial tamponade .
The mechanistic rationale for left atrial appendage (LAA) exclusion originates from transoesophageal echocardiographic and autopsy studies demonstrating that the majority of intracardiac thrombi in nonvalvular AF arise from the LAA. The LAA is anatomically predisposed to thrombus formation because of reduced contractility, blood stasis, complex trabeculations, and impaired endothelial function during AF. This has led to the belief that mechanical elimination of the LAA may be a feasible alternative to systemic anticoagulation.
Therefore, epicardial LAAC may be a feasible option to endocardial devices in AF patients with increased bleeding risk. The LAAOS III trial demonstrated that surgical LAAC was associated with a 33% risk reduction of stroke in patients undergoing cardiac surgery, and current guidelines recommend LAAC in patients with AF undergoing cardiac procedures.
Thoracoscopic epicardial LAAC using devices including the AtriClip™ and Penditure™ may overcome several limitations of endocardial approaches. Firstly, no intracardiac foreign body is implanted, which reduces the risk of device-related thrombi. TLAAC requires no septal puncture and provides more complete anatomical exclusion of the appendage, with lower risk of residual leak. Cartledge and colleagues reported a series of 175 patients who underwent standalone TLAAC and demonstrated a 99.4% procedural success rate (defined as residual stump <10mm) with low risk of procedural complications. One patient (0.6%) required conversion to sternotomy due to LAA bleeding. The cohort had a predicted annual stroke rate of 4.8% but no ischemic strokes were observed in study participants at a median follow up of 12.5 months, despite OACs being discontinued in 90.3% of patients at discharge.
Furthermore, evidence suggests that the AF triggers located in the LAA may contribute to maintenance of AF itself. As the epicardial devices also create an electrical isolation, epicardial exclusion may therefore provide both thromboembolic and electrophysiological benefits.
- Being tested
- Video-assisted thoracoscopic closure of the left atrial appendage using a closure device and discontinuation of treatment if the patient is treated with OAC
- Keywords
- Left atrial appendage closure, Atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-assisted thoracoscopic closure of the left atrial appendage using a closure device and discontinuation of treatment if the patient is treated with OACProcedure or surgery
Video-assisted thoracoscopic closure of the left atrial appendage using a closure device and discontinuation of treatment if the patient is treated with OAC. If indicated due to co-morbidities, patients will be prescribed platelet inhibitors instead.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care including best medical treatment | No intervention | Standard of care including best medical treatment. This may include treatment with OAC, antiplatelet therapy and both or none of the above, depending on the characteristics of the patient and the clinical judgement of the responsible physician. |
| Video-assisted thoracoscopic closure of the left atrial appendage using a closure device | Experimental | Video-assisted thoracoscopic closure of the left atrial appendage using a closure device and discontinuation of treatment if the patient is treated with OAC. If indicated due to co-morbidities, patients will be prescribed platelet inhibitors instead. Receives: Procedure: Video-assisted thoracoscopic closure of the left atrial appendage using a closure device and discontinuation of treatment if the patient is treated with OAC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants strokes, major bleedings, other arterial thromboembolic events and cardiovascular or unknown death measured per 100 patient years.
Intention to treat analysis of the primary outcome is the composite endpoint of stroke, major bleeding defined as a BARC III bleeding, other arterial thromboembolic events and cardiovascular or unknown death measured per 100 patient years.
Measured: Mean follow up of 3 years
Secondary outcomes (6)
Analysis of risk ratio for primary endpoint
As treated analysis of the primary endpoint. Analysis of risk ratio for primary endpoint. Components of the composite endpoint per 100 patient years, analyzed separately. Procedural success defined as residual stump <10mm using TOE intraoperatively and CT 60 days postoperatively. Healthcare cost-benefit analysis.
Measured: Mean follow up of 3 years
Proportion of patients receiving OAC treatment
Measured: Mean follow up of 3 years
Quality of life survey; 36-Item Short Form Survey Instrument (SF-36)
Quality of life (QoL) measured using the 36-Item Short Form Survey Instrument (SF-36)
Measured: Baseline, 2 months after inclusion and 1 and 2 years after inclusion
Number of patients with need for catheter ablation
Measured: Mean follow up of 3 years
Proportion of patients with need for new class I or III antiarrhythmic drugs for AF symptom reduction
Measured: Mean follow up of 3 years
Procedural success
Procedural success will be verified with CT 60 days after the procedure and defined as no residual flow in the LAA and a residual stump length of <10mm.
Measured: Day 60 postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Jan 2028 (estimated)
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATIONStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 936 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07705282
- Sponsor's protocol ID
- 2026-527335-34-00
- Acronym
- STELLA-AF
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Fox KAA, Virdone S, Bassand JP, Camm AJ, Goto S, Goldhaber SZ, Haas S, Kayani G, Koretsune Y, Misselwitz F, Oh S, Piccini JP, Parkhomenko A, Sawhney JPS, Stepinska J, Turpie AGG, Verheugt FWA, Kakkar AK; GARFIELD-AF investigators*. Do baseline characteristics and treatments account for geographical disparities in the outcomes of patients with newly diagnosed atrial fibrillation? The prospective GARFIELD-AF registry. BMJ Open. 2022 Jan 7;12(1):e049933. doi: 10.1136/bmjopen-2021-049933.
PubMed 34996784Romero J, Michaud GF, Avendano R, Briceno DF, Kumar S, Carlos Diaz J, Mohanty S, Trivedi C, Gianni C, Della Rocca D, Proietti R, Perrotta L, Bordignon S, Chun JKR, Schmidt B, Garcia M, Natale A, Di Biase L. Benefit of left atrial appendage electrical isolation for persistent and long-standing persistent atrial fibrillation: a systematic review and meta-analysis. Europace. 2018 Aug 1;20(8):1268-1278. doi: 10.1093/europace/eux372.
PubMed 29342299Di Biase L, Burkhardt JD, Mohanty P, Sanchez J, Mohanty S, Horton R, Gallinghouse GJ, Bailey SM, Zagrodzky JD, Santangeli P, Hao S, Hongo R, Beheiry S, Themistoclakis S, Bonso A, Rossillo A, Corrado A, Raviele A, Al-Ahmad A, Wang P, Cummings JE, Schweikert RA, Pelargonio G, Dello Russo A, Casella M, Santarelli P, Lewis WR, Natale A. Left atrial appendage: an underrecognized trigger site of atrial fibrillation. Circulation. 2010 Jul 13;122(2):109-18. doi: 10.1161/CIRCULATIONAHA.109.928903. Epub 2010 Jul 6.
PubMed 20606120Cartledge R, Suwalski G, Witkowska A, Gottlieb G, Cioci A, Chidiac G, Ilsin B, Merrill B, Suwalski P. Standalone epicardial left atrial appendage exclusion for thromboembolism prevention in atrial fibrillation. Interact Cardiovasc Thorac Surg. 2022 Mar 31;34(4):548-555. doi: 10.1093/icvts/ivab334.
PubMed 34871377Blackshear JL, Odell JA. Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation. Ann Thorac Surg. 1996 Feb;61(2):755-9. doi: 10.1016/0003-4975(95)00887-X.
PubMed 8572814Saw J, Holmes DR, Cavalcante JL, Freeman JV, Goldsweig AM, Kavinsky CJ, Moussa ID, Munger TM, Price MJ, Reisman M, Sherwood MW, Turi ZG, Wang DD, Whisenant BK. SCAI/HRS Expert Consensus Statement on Transcatheter Left Atrial Appendage Closure. JACC Cardiovasc Interv. 2023 Jun 12;16(11):1384-1400. doi: 10.1016/j.jcin.2023.01.011. Epub 2023 Mar 27.
PubMed 36990858Saw J. Long-Term Results With Left Atrial Appendage Closure: Watching the Watchman. J Am Coll Cardiol. 2017 Dec 19;70(24):2976-2978. doi: 10.1016/j.jacc.2017.10.056. Epub 2017 Nov 2. No abstract available.
PubMed 29104013Dukkipati SR, Kar S, Holmes DR, Doshi SK, Swarup V, Gibson DN, Maini B, Gordon NT, Main ML, Reddy VY. Device-Related Thrombus After Left Atrial Appendage Closure: Incidence, Predictors, and Outcomes. Circulation. 2018 Aug 28;138(9):874-885. doi: 10.1161/CIRCULATIONAHA.118.035090.
PubMed 29752398Reddy VY, Sievert H, Halperin J, Doshi SK, Buchbinder M, Neuzil P, Huber K, Whisenant B, Kar S, Swarup V, Gordon N, Holmes D; PROTECT AF Steering Committee and Investigators. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: a randomized clinical trial. JAMA. 2014 Nov 19;312(19):1988-98. doi: 10.1001/jama.2014.15192.
PubMed 25399274Holmes 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 24998121Lane DA, Meyerhoff J, Rohner U, Lip GYH. Patients' Perceptions of Atrial Fibrillation, Stroke Risk, and Oral Anticoagulation Treatment: An International Survey. TH Open. 2018 Jul 5;2(3):e233-e241. doi: 10.1055/s-0038-1666803. eCollection 2018 Jul.
PubMed 31249947Devereaux PJ, Anderson DR, Gardner MJ, Putnam W, Flowerdew GJ, Brownell BF, Nagpal S, Cox JL. Differences between perspectives of physicians and patients on anticoagulation in patients with atrial fibrillation: observational study. BMJ. 2001 Nov 24;323(7323):1218-22. doi: 10.1136/bmj.323.7323.1218.
PubMed 11719412Van Gelder IC, Rienstra M, Bunting KV, Casado-Arroyo R, Caso V, Crijns HJGM, De Potter TJR, Dwight J, Guasti L, Hanke T, Jaarsma T, Lettino M, Lochen ML, Lumbers RT, Maesen B, Molgaard I, Rosano GMC, Sanders P, Schnabel RB, Suwalski P, Svennberg E, Tamargo J, Tica O, Traykov V, Tzeis S, Kotecha D; ESC Scientific Document Group. 2024 ESC Guidelines for the management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2024 Sep 29;45(36):3314-3414. doi: 10.1093/eurheartj/ehae176. No abstract available.
PubMed 39210723Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KA, Califf RM; ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011 Sep 8;365(10):883-91. doi: 10.1056/NEJMoa1009638. Epub 2011 Aug 10.
PubMed 21830957Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD, Wallentin L; RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009 Sep 17;361(12):1139-51. doi: 10.1056/NEJMoa0905561. Epub 2009 Aug 30.
PubMed 19717844