Comparing LAAO and anticoagulation in stroke patients

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

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.

Why it matters

Who can join: the full rules

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 it's running

• Hospital Clinic Barcelona
  Barcelona, Barcelona, Spain Recruiting

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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.