Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsNA

The Fourth Left Atrial Appendage Occlusion Study

Sponsor: Hamilton Health Sciences Corporation

NCT ID: NCT05963698

View on ClinicalTrials.gov ↗

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.

Atrial FibrillationStroke, IschemicSystemic Embolism

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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
Inclusion Criteria: 1. (a) Persistent or permanent atrial fibrillation OR (b) Paroxysmal atrial fibrillation in participants with a history of ischemic stroke or systemic embolism 2. Increased risk of stroke, defined as a CHA2DS2-VASc stroke risk score of ≥ 4. \[Note: the acronym CHA2DS2-VASc stands for congestive heart failure, hypertension, age ≥75 (doubled), diabetes, stroke (doubled), vascular disease, age 65 to 74 and sex category (female).\] 3. Treatment with oral anticoagulants (Vitamin K agonist or factor Xa inhibitor) for at least 90 days prior to enrollment, AND no documented plan to discontinue treatment with oral anticoagulants for the expected duration of the trial. Exclusion Criteria: 1. Age \< 18 years 2. Current left atrial appendage thrombus 3. Prior left atrial appendage occlusion or removal (surgical or percutaneous) 4. Prior percutaneous atrial septal defect or patent foramen ovale closure 5. Prior atrial fibrillation ablation unless evidence of recurrent qualifying atrial fibrillation present at least 30 days following ablation 6. Planned atrial fibrillation ablation within 90 days of enrollment 7. Individuals being treated with direct thrombin inhibitors 8. Women of childbearing potential unless they agree to employ effective birth control methods throughout the study 9. Anticipated life-expectancy of \< 2 years 10. Patient unable or willing to give informed consent

Where Is This Study? (7 UK sites)

University Hospitals of Leicester NHS Trust

Leicester LE1 5WW, United Kingdom

Recruiting
Site contact (verified)
Jan Kovac, Prof., MDPrincipal Investigator

Nottingham University Hospital NHS Trust

Nottingham NG5 1PB, United Kingdom

Recruiting
Site contact (verified)
Ashan Gunarathne, MDPrincipal Investigator

Oxford University Hospitals NHS Foundation Trust

Oxford OX3 9DU, United Kingdom

Recruiting
Site contact (verified)
Tim Betts, MDPrincipal Investigator

University Hospitals Coventry and Warwickshire

Coventry CV2 2DX, United Kingdom

Recruiting
Site contact (verified)
Sandeep Panikker, MDPrincipal Investigator

University Hospitals Sussex NHS Trust

Worthing BN11 2DH, United Kingdom

Recruiting
Site contact (verified)
David Hildick-Smith, MDPrincipal Investigator

Liverpool Heart and Chest Hospital NHS Foundation Trust

Liverpool L14 3PE, United Kingdom

Recruiting
Site contact (verified)
Dhiraj Gupta, MDPrincipal Investigator

University Hospital Southampton NHS Foundation Trust

Southampton SO16 6YD, United Kingdom

Recruiting
Site contact (verified)
John Paisey, MDPrincipal Investigator

How to Get in Touch

Program Director

Sponsor contact

CONTACT

905-521-2100 LAAOS-4@phri.ca
Data sourced from ClinicalTrials.gov · Last verified: 2026-06