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

NCT07705282 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 936

Last updated 2026-07-15

No results posted yet for this study

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

Interventions

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

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.

Sponsors & Collaborators

  • Region Skane

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2028-01-01
Primary Completion
2031-12-31
Completion
2032-12-31
FDA Device
Yes

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07705282 on ClinicalTrials.gov