Prevention of Stroke by Left Atrial Appendage Closure in Atrial Fibrillation Patients After Intracerebral Hemorrhage

  • End date
    May 21, 2030
  • participants needed
  • sponsor
    Karolinska University Hospital
Updated on 27 January 2022
atrial fibrillation
intracerebral hemorrhage
left atrial appendage closure
anticoagulation therapy
left atrial appendage occlusion


Intracerebral hemorrhage (ICH) in patients with non-valvular atrial fibrillation (NVAF) poses a particular dilemma for thromboprophylaxis. Left atrial appendage occlusion (LAAO) is a non-pharmacological approach to prevent cardiac embolism in NVAF. The risk-benefit ratio of LAAO in patients with NVAF after ICH is unknown. The aim of STROKECLOSE is to assess the effect of LAAO to reduce the incidence stroke, bleeding and cardiovascular mortality in patients with NVAF and prior ICH.


Methods/design: A multicenter prospective randomized open-label clinical trial with blinded outcome evaluation (PROBE design) and blinded safety outcome assessment. The active comparison LAAO is tested against medical therapy in a 2:1 stratified randomization.

Study population: Patients should have had an ICH within 6 months prior to enrollment and have NVAF with increased risk of stroke or systemic embolism, as indicated by a CHA2DS2VASc score >2. In total 750 patients will be included. Active enrollment ensues over 3 years followed by 5 years follow-up and a long-term follow-up at 10 years.

Intervention and control: The intervention group will be treated by LAAO, using the Amplatzer Amulet device. Implantation requires a catheterization procedure using venous access and transseptal puncture and is guided by angiography, fluoroscopy and transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE). Recommended post-implant antithrombotic therapy includes aspirin (ASA) therapy for at least 6 months, with or without clopidogrel for the first 45 days after implantation. The control group will receive medical therapy, delivered according to national standards and guidelines at the treating physicians' discretion. This may include oral anticoagulation (OAC) (vitamin-K antagonists, VKA), non-VKA OAC, antiplatelet therapy or no antithrombotic therapy at all.

Main study outcomes: The primary outcome is the composite endpoint of stroke (ischemic and hemorrhagic), systemic embolism, life-threatening or major bleeding and all-cause mortality, assessed over at least two years. Secondary outcome examines various early and late safety outcome parameters.

Condition Atrial Fibrillation, Stroke, Intracerebral Hemorrhage
Treatment Medical therapy, LAAO
Clinical Study IdentifierNCT02830152
SponsorKarolinska University Hospital
Last Modified on27 January 2022


Yes No Not Sure

Inclusion Criteria

A diagnosis of paroxysmal, persistent or long-standing NVAF with CHA2DS2VASc score >2\
Clinical and CT/MRI evidence of ICH within 6 months but not less than 4 weeks prior to enrollment
Age > 18 years
Signed informed consent

Exclusion Criteria

ICH secondary to vascular malformation or tumors
Estimated life expectancy of less than 1 year at eligibility assessment
mRS > 3 at enrollment
Contraindications to LAAO known at the time of enrollment, such as LAA thrombus or systemic infection, prior surgical LAA excision
Planned combined interventional procedures at the time of enrollment
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