Actively Recruiting

Phase Not Applicable
Age: 18Years - 95Years
All Genders
NCT06869811

Oral Anticoagulation Versus Left Atrial Appendage Occlusion Added to Direct Oral Anticoagulation in Patients with Stroke Despite Oral

Led by Hospital Clinic of Barcelona · Updated on 2025-03-11

380

Participants Needed

1

Research Sites

156 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

A total of 380 patients with ischemic stroke despite OAC will be included. Patients will be randomized 1:1 to the best medical treatment (control) or the combination of LAAO and DOAC or OAC. The study's primary endpoint will be the occurrence of a cardioembolic event (ischemic stroke or arterial peripheral embolism) within the first 12 months after inclusion.

CONDITIONS

Official Title

Oral Anticoagulation Versus Left Atrial Appendage Occlusion Added to Direct Oral Anticoagulation in Patients with Stroke Despite Oral

Who Can Participate

Age: 18Years - 95Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Cardioembolic ischemic stroke despite OAC or DOAC within the last 6 months
  • Documented atrial fibrillation (valvular or non-valvular)
  • Left atrial appendage suitable for closure (if thrombus, only distal)
  • Functional status without severe disability (mRS < 4) at inclusion
  • No contraindication for LAA assessment by CT or 3D-TEE
  • Age over 18 years
  • Life expectancy greater than 1 year
  • Able to understand written consent before inclusion
  • Able and willing to attend follow-up visits and tests
Not Eligible

You will not qualify if you...

  • Absolute contraindication to OAC/DOAC
  • Non-compliance with OAC/DOAC in the week before index stroke
  • Lacunar ischemic stroke
  • Symptomatic carotid disease with >50% narrowing unless previous stent or endarterectomy with <50% narrowing
  • Planned invasive cardiac intervention or surgery within 3 months after randomization (except study procedures)
  • High risk for general anesthesia if planned for study procedure
  • Non-treated patent foramen ovale or implanted PFO closure device
  • Presence of inferior vena cava filter
  • Contraindications for percutaneous catheterization
  • Contraindications for TEE/TOE (e.g., esophageal varices, stricture, cancer history)
  • Catheter ablation for AF or atrial flutter within 60 days before randomization
  • Myocardial infarction within 90 days before randomization
  • NYHA Class IV congestive heart failure
  • Left ventricular ejection fraction ≤ 30%
  • Obliterated or surgically ligated LAA
  • Thrombocytopenia (<50,000 platelets/μL) or anemia (hemoglobin <10 g/dL) requiring transfusions
  • Hypersensitivity to device components (e.g., nickel allergy)
  • Allergy to contrast media if angio-CT needed and TEE/TOE not possible
  • Participation in conflicting clinical studies
  • Pregnancy, breastfeeding, or planned pregnancy during the study
  • Active endocarditis or bacteremia
  • Other conditions limiting participation or follow-up as judged by the investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hospital Clinic Barcelona

Barcelona, Barcelona, Spain, 08036

Actively Recruiting

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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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