Could a One-Time keyhole surgery replace daily blood thinners for some heart patients?
NCT ID NCT07705282
First seen Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time
Summary
This trial compares a minimally invasive surgery that closes off a small heart pouch (the left atrial appendage) to standard blood-thinning medication in people with atrial fibrillation who have a high risk of bleeding. The goal is to see if the surgery can prevent strokes, major bleeds, and other heart-related events as well as or better than daily pills. Participants are either already on blood thinners or cannot take them due to medical reasons.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- video-assisted thoracoscopic closure of the left atrial appendage using a closure device
- What this could lead to
- If successful, this procedure could offer a safe alternative to long-term blood thinners for people with atrial fibrillation who are at high risk of bleeding.
- What could go wrong
- This is a large trial, but surgery carries risks like infection or complications from anesthesia. The procedure may not prove as effective as blood thinners in preventing strokes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 936 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2028
An estimate. Start dates often move.
- Expected to finish
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Dec 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 18 years and any of criteria 2-3 2. AF with a CHA2DS2-VA score ≥2 and a HAS-BLED score ≥3 or other clinically significant bleeding condition and ongoing OAC treatment 3. 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). Exclusion Criteria: 1. Clinical frailty score ≥5 2. Indication for OAC other than AF 3. Indication for dual antiplatelet therapy, if OAC is discontinued 4. Previous open-heart surgery 5. Present indication for cardiac surgery 6. Present indication for ablation for atrial fibrillation 7. Previous radiation therapy of the chest, due to malignancy 8. Previous pericarditis or myocarditis 9. Previous surgery including access to the left pleural space 10. Documented FEV1\<70% or other significant pulmonary disease (including but not restricted to fibrosis, pulmonary post-covid syndrome, cystic fibrosis) 11. Ongoing treatment with corticosteroids or previous treatment for more than 3 consecutive months. 12. Allergy to contrast media 13. Patient already included in another interventional clinical trial 14. Patient listed abroad, which would render them to be lost to follow-up after discharge 15. Patient does not understand study information given in the local language or, for other reasons, is deemed unfit to participate according to the investigators
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Skånes universitetssjukhus
Lund, Sweden
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- New heart camera aims to make procedures safer
- Could a tiny neck filter stop strokes in heart patients?