Standalone Thoracoscopic Left Atrial Appendage Closure Versus Medical Therapy in Atrial Fibrillation

NCT07705282 | Not Yet Recruiting FDA Device

• 1 other identifier: 2026-527335-34-00
• Study Type: interventional
• Target: 936
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION; Oral Anticoagulation; Thoracotomy

Keywords

Left atrial appendage closure; Atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• 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.

  Mean follow up of 3 years

Secondary Outcomes (6)

• Analysis of risk ratio for primary endpoint

  Mean follow up of 3 years

• Proportion of patients receiving OAC treatment

  Mean follow up of 3 years

• Quality of life survey; 36-Item Short Form Survey Instrument (SF-36)

  Baseline, 2 months after inclusion and 1 and 2 years after inclusion

• Number of patients with need for catheter ablation

  Mean follow up of 3 years

• Proportion of patients with need for new class I or III antiarrhythmic drugs for AF symptom reduction

  Mean follow up of 3 years

Study Arms (2)

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.

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

Interventions

Video-assisted thoracoscopic closure of the left atrial appendage using a closure device and discontinuation of treatment if the patient is treated with OAC 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. If indicated due to co-morbidities, patients will be prescribed platelet inhibitors instead.

Video-assisted thoracoscopic closure of the left atrial appendage using a closure device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Skånes universitetssjukhus

Lund, Sweden

Location

Related Publications (19)

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MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Igor Zindovic, MD, Phd

CONTACT

+4646173300; igor.zindovic@skane.se

Karl Teurneau-Hermansson, MD, PhD

CONTACT

+4646173300; Karl.Teurneau-Hermansson@skane.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 15, 2026
• Study Start (Estimated): January 1, 2028
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2032
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)