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

NCT02830152 · tracked via the Priya Life Science Denmark tracker

Sponsor

Karolinska Institutet

Phase

Not applicable

Started

2017-05-03

Last updated

2024-06-12

Condition(s) studied

Atrial FibrillationStrokeIntracerebral Hemorrhage

Investigational drug(s) / intervention(s)

LAAOMedical Therapy

LAAO: The left atrial appendage is occluded with the AMPLATZER™ Amulet™ device, which offers a conformable disc and lobe designed for complete occlusion of the left atrial appendage.

Medical Therapy: Available options included in Medical therapy are: anticoagulation with OAC or NOAC, antiplatelet therapy (including monotherapy and dual antiplatelet therapy) and no pharmacological antithrombotic therapy.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Composite endpoint of stroke (ischemic or hemorrhagic), systemic embolism, life-threatening or major bleeding and all-cause mortality — up to 5 years after randomization
This endpoint will be assessed in patients with paroxysmal, persistent or long-standing NVAF and with ICH within 6 months prior to enrollment. The effect of LAAO will be compared to medical therapy at the treating physician's discretion as a control.

Trial sites (17)

Facility	City	Region
Aarhus University Hospital	Aarhus	Denmark
Bispebjerg University Hospital	Bispebjerg	Denmark
Rikshospitalet Glostrup	Glostrup Municipality	Denmark
Herlev sjukhus	Herlev	Denmark
Odenses Universitetssjukhus	Odense	Denmark
Helsinki University Hospital	Helsinki	Finland
North Karelia Central Hospital	Joensuu	Finland
Kuopio University Hospital	Kuopio	Finland
Turku University Hospital	Turku	Finland
Vaasa Centralsjukhus	Vaasa	Finland
Haukeland Universitetssjukhus	Bergen	Norway
Oslo University Hospital	Oslo	Norway
Sahlgrenska University Hospital	Gothenburg	Sweden
Universitetssjukhuset Skåne	Lund	Sweden
Universitetssjukhuset	Örebro	Sweden
Danderyd Hospital	Stockholm	Sweden
Akademiska sjukhuset	Uppsala	Sweden

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02830152 on ClinicalTrials.gov ↗ ← All trials in Denmark