At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- WATCHMAN device (device)
- How long the study runs
- Study runs about 73 months (dates as stated)
- About the drug or intervention
- WATCHMAN device — device: Participants will undergo endovascular left atrial appendage occlusion with the WATCHMAN device
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, called The Fourth Left Atrial Appendage Occlusion Study, is looking at people with atrial fibrillation (an irregular heart rhythm) who are at increased risk of stroke or a blood clot elsewhere in the body (a systemic embolism). It is being run by Hamilton Health Sciences Corporation.
Who can take part
- Adults aged 18 or over with either long-lasting (persistent or permanent) atrial fibrillation, or intermittent (paroxysmal) atrial fibrillation if they have previously had an ischaemic stroke or a blood clot elsewhere in the body
- A higher risk of stroke, shown by a CHA2DS2-VASc score of 4 or more (this is a scoring system doctors use that counts things like heart failure, high blood pressure, age, diabetes, previous stroke, vascular disease and sex)
- Already taking blood-thinning medicines (either a vitamin K medicine or a factor Xa inhibitor) for at least 90 days before joining, with no plans to stop this treatment during the trial
Who may not be able to
- People under 18
- Anyone with a blood clot in the left atrial appendage (a small pocket in the heart) at the moment
- Anyone who has already had the left atrial appendage closed or removed
- Anyone who has already had a hole in the heart closed with a device (for an atrial septal defect or patent foramen ovale)
- People who have had atrial fibrillation ablation (a procedure to treat the heart rhythm) unless the atrial fibrillation came back at least 30 days afterwards
- Anyone planning to have atrial fibrillation ablation within 90 days of joining
- People taking medicines called direct thrombin inhibitors
- Women who could become pregnant, unless they agree to use effective birth control throughout the study
- Anyone expected to live less than 2 years
- Anyone unable or unwilling to give informed consent
What taking part involves
- • Not stated — ask the trial team
Time commitment: Visits and duration not stated — ask the trial team; participants need to stay on their blood-thinning medicine with no planned breaks during the trial.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 4,000
- Started
- 2023-11-30
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for atrial fibrillation
- • NA - 4,000 participants
- • LAAOS-4 aims to determine if catheter-based endovascular left atrial appendage occlusion prevents ischemic stroke or systemic embolism in participants with atrial fibrillation, who remain at high risk of stroke, despite receiving ongoing treatment with oral anticoagulation
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with atrial fibrillation
Where?
- • Leicester - University Hospitals of Leicester NHS Trust
- • Nottingham - Nottingham University Hospital NHS Trust
- • Oxford - Oxford University Hospitals NHS Foundation Trust
- • Coventry - University Hospitals Coventry and Warwickshire
- • +3 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
LAAOS-4 aims to determine if catheter-based endovascular left atrial appendage occlusion prevents ischemic stroke or systemic embolism in participants with atrial fibrillation, who remain at high risk of stroke, despite receiving ongoing treatment with oral anticoagulation.
More detail
LAAOS-4 is a multicentre, prospective, open-label, randomized controlled trial with blinded assessment of endpoints (PROBE) to determine if catheter-based endovascular left atrial appendage occlusion prevents ischemic stroke or systemic embolism in participants with atrial fibrillation, who remain at high risk of stroke, despite receiving ongoing treatment with oral anticoagulation.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓(a) Persistent or permanent atrial fibrillation OR (b) Paroxysmal atrial fibrillation in participants with a history...
Who cannot take part
- ✗Age \< 18 years
- ✗Current left atrial appendage thrombus
- ✗Prior left atrial appendage occlusion or removal (surgical or percutaneous)
- ✗Prior percutaneous atrial septal defect or patent foramen ovale closure
- ✗Prior atrial fibrillation ablation unless evidence of recurrent qualifying atrial fibrillation present at least 30...
See the full criteria
Where Is This Study? (7 UK sites)
University Hospitals of Leicester NHS Trust
Leicester LE1 5WW, United Kingdom
Nottingham University Hospital NHS Trust
Nottingham NG5 1PB, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford OX3 9DU, United Kingdom
University Hospitals Coventry and Warwickshire
Coventry CV2 2DX, United Kingdom
University Hospitals Sussex NHS Trust
Worthing BN11 2DH, United Kingdom
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool L14 3PE, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton SO16 6YD, United Kingdom
How to Get in Touch
Program Director
Sponsor contactCONTACT
