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New treatment option for Atrial Fibrillation
Official title The Fourth Left Atrial Appendage Occlusion Study
ClinicalTrials.gov ID: NCT05963698
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- (a) Persistent or permanent atrial fibrillation OR (b) Paroxysmal atrial fibrillation in participants with a history of ischemic stroke or systemic...
- Increased risk of stroke, defined as a CHA2DS2-VASc stroke risk score of ≥ 4. [Note: the acronym CHA2DS2-VASc stands for congestive heart failure...
- Treatment with oral anticoagulants (Vitamin K agonist or factor Xa inhibitor) for at least 90 days prior to enrollment, AND no documented plan to...
You likely can't join if
- 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 days following ablation
- Planned atrial fibrillation ablation within 90 days of enrollment
See the full eligibility criteria
- (a) Persistent or permanent atrial fibrillation OR (b) Paroxysmal atrial fibrillation in participants with a history of ischemic stroke or systemic embolism
- 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...
- 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...
- 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 days following ablation
- Planned atrial fibrillation ablation within 90 days of enrollment
- Individuals being treated with direct thrombin inhibitors
- Women of childbearing potential unless they agree to employ effective birth control methods throughout the study
- Anticipated life-expectancy of \< 2 years
- Patient unable or willing to give informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Jonesboro, Arkansas, United States
- Fountain Valley, California, United States
- Loma Linda, California, United States
- Pasadena, California, United States
- Sacramento, California, United States
- Atlantis, Florida, United States
- Jacksonville, Florida, United States
- Largo, Florida, United States
- Ocala, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Boise, Idaho, United States
- Coeur d'Alene, Idaho, United States
- Evanston, Illinois, United States
- Rock Island, Illinois, United States
- Indianapolis, Indiana, United States
- West Des Moines, Iowa, United States
- Kansas City, Kansas, United States
- Lexington, Kentucky, United States
+ 100 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Jonesboro, Arkansas, United States; Fountain Valley, California, United States; Loma Linda, California, United States; Pasadena, California, United States; Sacramento, California, United States and 114 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.