NCT06869811

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
380

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Jul 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Jul 2024Jul 2027

Study Start

First participant enrolled

July 22, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 11, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2027

Last Updated

March 11, 2025

Status Verified

July 1, 2024

Enrollment Period

2.6 years

First QC Date

March 5, 2025

Last Update Submit

March 5, 2025

Conditions

Left Atrial Appendage Closure

Keywords

LAAOStrokeOral Anticoagulation

Outcome Measures

Primary Outcomes (1)

  • Primary Endpoint

    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.

    12 months

Study Arms (2)

Best medical treatment

ACTIVE COMPARATOR

The best medical treatment selected by the neurologist including change OAC/DOAC or intensification of the antithrombotic treatment.

Device: LAA Closurse

Left atrial appendage occlusion + DOAC or OAC

ACTIVE COMPARATOR

LAA Occlusion + DOAC (unless there is a compelling use of OAC like in a mechanical valve).

Device: LAA Closurse

Interventions

LAA ClosurseDEVICE

LAA Closure + DOAC or OAC

Best medical treatmentLeft atrial appendage occlusion + DOAC or OAC

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • No contraindication for LAA assessment by CT or 3D-TEE.
  • \>18 years
  • Life expectancy \>1year
  • Able and willing to return for follow-up visits and tests.

You may not qualify if:

  • 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.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic Barcelona

Barcelona, Barcelona, 08036, Spain

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 arms Treatment vs. Procedure + treatment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2025

First Posted

March 11, 2025

Study Start

July 22, 2024

Primary Completion (Estimated)

February 22, 2027

Study Completion (Estimated)

July 22, 2027

Last Updated

March 11, 2025

Record last verified: 2024-07

Locations

ES(1)