NCT07705282Not yet recruiting
Standalone Thoracoscopic Left Atrial Appendage Closure Versus Medical Therapy in Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 15 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 936 (estimated)
- First submitted
- 6 Jul 2026
- Start date
- 1 Jan 2028
- Primary completion date
- 31 Dec 2031
- Lead sponsor
- Region Skane
- Diseases
- Atrial fibrillation
- NCT number
- NCT07705282
What you commit to
- Study type: Interventional
- Planned participants: 936
- From 1 Jan 2028 to the primary completion date, 31 Dec 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Indication for dual antiplatelet therapy, if OAC is discontinued
- Previous open-heart surgery
- Previous radiation therapy of the chest, due to malignancy
- Previous pericarditis or myocarditis
- Previous surgery including access to the left pleural space
- Ongoing treatment with corticosteroids or previous treatment for more than 3 consecutive months.
Other illness
- Present indication for cardiac surgery
- Documented FEV1\<70% or other significant pulmonary disease (including but not restricted to fibrosis, pulmonary post-covid syndrome, cystic fibrosis)
- Allergy to contrast media
Other
- Clinical frailty score ≥5
- Indication for OAC other than AF
- Present indication for ablation for atrial fibrillation
- 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
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Skanes universitetssjukhus Coordinator of this site? Confirm its status | Lund | Sweden | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.