Actively Recruiting
Oral Anticoagulation Versus Left Atrial Appendage Occlusion Added to Direct Oral Anticoagulation in Patients with Stroke Despite Oral (ADD-LAAO TRIAL)
Led by Hospital Clinic of Barcelona · Updated on 2025-03-11
380
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
H
Hospital Clinic of Barcelona
Lead Sponsor
F
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research focuses on patients who have had an ischemic stroke despite being treated with oral anticoagulation (OAC). It aims to compare whether adding a device called left atrial appendage occlusion (LAAO) plus direct oral anticoagulants (DOAC) or OAC results in fewer cardioembolic events like strokes or arterial embolisms within 12 months compared to the best medical treatment chosen by a neurologist. The study addresses the challenge of managing patients who continue to have strokes despite current anticoagulant therapies, seeking a better balance between preventing clots and avoiding bleeding risks. Participants will be randomly assigned to one of two groups: the control group receiving the best medical treatment, which may include changes or intensification of OAC or DOAC therapy, and the intervention group receiving LAAO plus DOAC or OAC unless there is a specific reason to use OAC alone. The LAAO is a device implanted in the heart to reduce stroke risk. Treatment and follow-up will continue for at least 12 months to monitor outcomes. During the study, participants will undergo regular assessments including imaging tests such as CT or 3D transesophageal echocardiography to evaluate the heart and the suitability for LAA closure. Researchers will track the occurrence of cardioembolic events and monitor safety throughout the year. Participants must be able to attend follow-up visits and provide consent. The study duration for each participant is at least one year, with data collected to evaluate the primary outcome of stroke or embolism events.
CONDITIONS
Brief Title
Oral Anticoagulation Versus Left Atrial Appendage Occlusion Added to Direct Oral Anticoagulation in Patients with Stroke Despite Oral
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cardioembolic ischemic stroke despite oral anticoagulation or direct oral anticoagulants within the last 6 months
- Documented atrial fibrillation, either valvular or non-valvular
- Left atrial appendage suitable for closure (if thrombus, only distal)
- Functional status without severe disability (modified Rankin Scale less than 4)
- No contraindication for left atrial appendage assessment by CT or 3D transesophageal echocardiography
- Age over 18 years
- Life expectancy greater than 1 year
- Able to understand and provide written informed consent
- Able and willing to return for follow-up visits and tests
You will not qualify if you...
- Absolute contraindication to oral anticoagulants or direct oral anticoagulants
- Non-compliance with oral anticoagulants or direct oral anticoagulants more than 24 hours within the last week before stroke
- Lacunar ischemic stroke
- Symptomatic carotid disease with over 50% narrowing or recent ipsilateral symptoms
- Planned invasive cardiac intervention or surgery within 3 months after randomization, except study procedures
- High risk for general anesthesia or planned general anesthesia for study procedure
- Untreated patent foramen ovale or implanted closure device
- Inferior vena cava filter present
- Contraindications for percutaneous catheterization procedures
- Contraindications for transesophageal echocardiography
- Catheter ablation for atrial fibrillation or flutter within 60 days before randomization
- Myocardial infarction within 90 days before randomization
- New York Heart Association Class IV heart failure
- Left ventricular ejection fraction 30% or less
- Obliterated or surgically ligated left atrial appendage
- Low platelet count or anemia requiring transfusion
- Allergy to device materials or contrast media if needed
- Active participation in conflicting clinical studies
- Pregnancy, breastfeeding, or planned pregnancy during the study
- Active endocarditis or bloodstream infection
- Other medical, social, or psychological conditions limiting participation or compliance with follow-up requirements
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to 12 months
Participants randomized to the device group receive left atrial appendage occlusion along with direct oral anticoagulation or oral anticoagulation. Participants randomized to the control group receive the best medical treatment selected by their neurologist, which may include changes or intensification of anticoagulant therapy.
Regular visits as determined by treating physicians
Duration - Up to 12 months after intervention
Participants are monitored for the occurrence of cardioembolic events (ischemic stroke or arterial peripheral embolism) and other health outcomes following their assigned treatment.
Visits scheduled up to 12 months
Trial Site Locations
Total: 1 location
1
Hospital Clinic Barcelona
Barcelona, Barcelona, Spain, 08036
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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