Active — Not RecruitingNot Applicable

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

Denmark750 participantsStarted 2017-05-03

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * A diagnosis of paroxysmal, persistent or long-standing NVAF with CHA2DS2VASc score \>2. * Clinical and CT/MRI evidence of ICH within 12 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 * Prior surgical LAA excision * Planned combined interventional procedures at the time of enrollment

What they're measuring

Composite endpoint of stroke (ischemic or hemorrhagic), systemic embolism, life-threatening or major bleeding and all-cause mortality

Timeframe: up to 5 years after randomization

Trial details

NCT IDNCT02830152

SponsorKarolinska Institutet

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

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