Catheter-based closure of the left atrial appendage to prevent strokes in patients with atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The Fourth Left Atrial Appendage Occlusion Study (LAAOS-4) is a multicenter, prospective, open-label, randomized controlled trial designed to evaluate the effectiveness of catheter-based endovascular left atrial appendage occlusion in preventing ischemic stroke or systemic embolism in patients with atrial fibrillation. Participants will be those at high risk for stroke despite ongoing treatment with oral anticoagulants. The study will utilize the WATCHMAN device for the occlusion procedure, with endpoints assessed in a blinded manner to ensure objectivity. This approach aims to provide a new intervention for patients who remain at risk despite standard anticoagulation therapy.

Why it matters

Who can join: the full rules

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 it's running

• Arrhythmia Research Group
  Jonesboro, Arkansas, United States Recruiting
• Memorial Health Services
  Fountain Valley, California, United States Recruiting
• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• Southern California Permanente Medical Group
  Pasadena, California, United States Recruiting
• Sutter Valley Hospitals dba Sutter Institute for Medical Research
  Sacramento, California, United States Recruiting
• Christiana Care Health Services, Inc.
  Wilmington, Delaware, United States Recruiting

+100 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Jeff Healey — Hamilton Health Sciences Corporation
• Study coordinator: Program Director
• Email: LAAOS-4@phri.ca
• Phone: 905-521-2100

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using an implantable cardiac monitor to detect atrial fibrillation in stroke patients

  This study is testing whether an implantable heart monitor can help find atrial fibrillation in stroke patients to see if it can lead to better treatment and prevent future strokes.

  Recruiting National and Kapodistrian University of Athens · Athens · NCT05494034

• Identifying echocardiographic predictors of atrial fibrillation

  This study is testing if certain heart ultrasound measurements can help find atrial fibrillation in patients who have had a stroke or a mini-stroke.

  Recruiting Karl Landsteiner University of Health Sciences · Tulln · NCT05044208

• Research on health inequality and genetic disparity in cardiovascular diseases

  This study is trying to understand how health differences and genetics affect heart diseases in people from various ethnic backgrounds in the UK to help improve treatments for everyone.

  Recruiting Future Genetics Limited · Wolverhampton, West Midlands · NCT03987633

• AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals

  This study tests AI-powered tools on real-world stroke patients to see if they can improve pre-hospital triage, diagnosis, and outcome prediction while data stay securely within each hospital.

  Recruiting at 2 sites Hospital Universitari Vall d'Hebron Research Institute · Leuven and 6 other locations · NCT07924371

• Paired VNS: How the Brain and Pupils Respond in Stroke Patients

  This study tests real-time physiologic responses to paired VNS in adults with chronic motor impairment after ischemic stroke to help tailor dosing.

  Recruiting MGH Institute of Health Professions · Boston, Massachusetts · NCT07922200

• Left-atrial Fibrosis in Persistent Atrial Fibrillation and Its Comorbidities

  This study tests how comorbid conditions like sleep apnea and primary aldosteronism relate to left-atrial fibrosis and AF recurrence in patients undergoing ablation.

  Recruiting University Hospital Augsburg · Augsburg, Bavaria · NCT07857044

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.