Standalone Thoracoscopic Left Atrial Appendage Closure Versus Medical Therapy in Atrial Fibrillation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Skane
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Clinical frailty score ≥5
Indication for OAC other than AF
Indication for dual antiplatelet therapy, if OAC is discontinued
Previous open-heart surgery
Trial design
Design model
Parallel
Treatments tested in this trial
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/SurgeryVideo-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.
Treatment groups
936 Participants
are divided into 2 treatment groupsGroup A: Standard of care including best medical treatmentNo intervention 0 interventions
Group B: Video-assisted thoracoscopic closure of the left atrial appendage using a closure deviceExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Mean follow up of 3 yearsSecondary outcomes
1
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.
Time frame
Mean follow up of 3 years2
Proportion of patients receiving OAC treatment
Time frame
Mean follow up of 3 years3
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)
Time frame
Baseline, 2 months after inclusion and 1 and 2 years after inclusion4
Number of patients with need for catheter ablation
Time frame
Mean follow up of 3 yearsSponsors and contacts
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Source ClinicalTrials.gov
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