Prevention of Stroke by Left Atrial Appendage Closure in Atrial Fibrillation Patients After Intracerebral Hemorrhage
NCT ID: NCT02830152
Last Updated: 2024-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
750 participants
INTERVENTIONAL
2017-05-03
2028-12-31
Brief Summary
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Detailed Description
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Study population: Patients should have had an ICH within 12 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Left Atrial Appendage Occlusion (LAAO)
The intervention is implantation of Amplatzer Amulet LAAO device within two months after randomization. Device implantation comprises a catheterization procedure using venous access and a transseptal puncture to obtain access to the left atrium (LA). Procedural imaging guidance is left to the physician's discretion and may include several techniques such as angiography/fluoroscopy, transesophageal echocardiography (TEE) and/or intracardiac echocardiography (ICE). Recommended post-implant antithrombotic therapy includes ASA therapy for at least 6 months, which may be combined with clopidogrel for the first 45 days after implantation.
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
The optimal medical therapy of stroke prevention in non-valvular atrial fibrillation (NVAF) after intracerebral hemorrhage (ICH) is not known. Therefore, it will be left to the discretion of the treating physician to decide if, when, and which pharmacological therapy will be prescribed. Available options include anticoagulation with oral anticoagulation (OAC) or novel oral anticoagulants (NOAC), antiplatelet therapy (including monotherapy and dual antiplatelet therapy) and no pharmacological antithrombotic therapy.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Karolinska Institutet
OTHER
Responsible Party
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Per Wester
Principal investigator
Principal Investigators
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Per Wester, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Clinical Sciences, Karolinska Institute, Danderyds hospital
Locations
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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
Countries
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Other Identifiers
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STROKECLOSE
Identifier Type: -
Identifier Source: org_study_id
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