Comparing LAAO and anticoagulation in stroke patients

Oral Anticoagulation Versus Left Atrial Appendage Occlusion Added to Direct Oral Anticoagulation in Patients with Stroke Despite Oral (ADD-LAAO TRIAL)

This study is testing if adding a procedure to close off a part of the heart can help stroke patients who are already taking blood thinners and still having strokes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 380 (estimated)
• Ages: 18 Years to 95 Years
• Sex: All
• Sponsor: Hospital Clinic of Barcelona (Academic / other)
• Locations: 1 site (Barcelona, Barcelona)
• Trial ID: NCT06869811 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of combining left atrial appendage occlusion (LAAO) with direct oral anticoagulation (DOAC) or oral anticoagulation (OAC) in patients who have experienced an ischemic stroke despite being on anticoagulant therapy. A total of 380 patients will be randomized into two groups: one receiving the combination treatment and the other receiving the best medical treatment as determined by their neurologist. The primary goal is to assess the occurrence of recurrent cardioembolic events, such as ischemic stroke or arterial peripheral embolism, within 12 months of treatment. This approach seeks to address the growing challenge of managing patients with atrial fibrillation who continue to have strokes despite anticoagulation.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with a history of cardioembolic ischemic stroke despite OAC or DOAC within the last 6 months and documented atrial fibrillation.

Not a fit: Patients with absolute contraindications to anticoagulation or those who have experienced lacunar ischemic strokes may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients who suffer strokes despite being on anticoagulation therapy.

How similar studies have performed: This study represents a novel approach, as there have been limited randomized trials directly comparing LAAO combined with anticoagulation to optimal medical treatment in this patient population.

Eligibility criteria

Inclusion Criteria:

* Cardioembolic\* Ischemic stroke despite OAC or DOAC within the last 6 months.
* Documented AF (either valvular or non-valvular AF).
* LAA suitable for closure (if LAA thrombus, just distal).
* Functional status at inclusion with no severe disability (mRS\<4).
* No contraindication for LAA assessment by CT or 3D-TEE.
* \>18 years
* Life expectancy \>1year
* Able to understand written consent prior to the trial inclusion.
* Able and willing to return for follow-up visits and tests.

Exclusion Criteria:

* Absolute contraindication to OAC/DOAC.
* Non-compliance of OAC/DOAC \>24 hours within the last week before the index stroke (\>1 dose per - - Antagonist Vit K and \>2 doses per DOAC).
* Lacunar Ischemic Stroke.
* Symptomatic carotid disease (defined as \> 50% lumen diameter narrowing on CTA, MRA, or TCD with symptoms of ipsilateral transient or visual TIA evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke); if subject has a history of carotid stent or endarterectomy the subject is eligible if there is \< 50% lumen diameter narrowing.
* Planned cardiac intervention or surgery, which is invasive or requires sedation or anesthesia, within 3 months following randomization, other than study-related procedures such as LAAO and cardiac imaging (if applicable).
* In the opinion of the investigator, is considered at high risk for general anesthesia and general anesthesia is planned for the study procedure.
* Non-treated patent foramen ovale (PFO) or PFO closure device implanted.
* Inferior vena cava filter.
* Has any of the customary contraindications for a percutaneous catheterization procedure (e.g. subject is too small to accommodate the ICE probe (if planned) or required catheters, or subject has - active infection or bleeding disorder).
* Customary contraindications for TEE/TOE (e.g., presence of esophageal varices, esophageal stricture, or history of esophageal cancer).
* Underwent catheter ablation for AF or atrial flutter within 60 days prior to randomization.
* Experienced myocardial infarction within 90 days prior to randomization.
* New York Heart Association Class IV Congestive Heart Failure.
* Left ventricular ejection fraction ≤ 30% (per most recent assessment).
* LAA is obliterated or surgically ligated.
* Thrombocytopenia (defined as \< 50,000 platelets per microliter (\<50 x 109/L) or anemia (defined as hemoglobin \< 10 g/dL) requiring transfusions.
* Hypersensitivity to any portion of the device material or individual components of the Amulet LAA occluder device (e.g., nickel allergy).
* Allergy to contrast media if the patient needs angio-CT and cannot undergo TEE/TOE.
* Actively enrolled in, or plans to enroll in, a concurrent clinical study in which the active treatment arm may confound the results of this trial.
* Is pregnant or breastfeeding, or pregnancy is planned during the course of the investigation.
* Active endocarditis or other infection producing bacteremia.
* Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the Investigator's opinion, could limit the subject's ability to participate in clinical investigation or to comply with follow up requirements, or impact the scientific soundness of the clinical investigation results.

Where this trial is running

Barcelona, Barcelona

• Hospital Clinic Barcelona — Barcelona, Barcelona, Spain (Recruiting)

Conditions Left Atrial Appendage Closure; LAAO; Stroke; Oral Anticoagulation