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

• Status: Recruiting
• Trial end date: 2030-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karolinska University Hospital
• Collaborators: Abbott Medical Devices; St. Jude Medical

Criteria

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