Cerebral Protection in Transcatheter Left Atrial Appendage Occlusion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSilesian Centre for Heart Diseases
About this trial
The study aims to assess the effect of the use of neuroprotection in transcutaneous occlusion of the left atrial appendage in patients with atrial fibrillation on the risk of perioperative silent brain ischemia and associated cognitive impairment and depression.
Eligibility criteria
Qualifiers
18 Years and older
Subject able to provide signed informed consent.
Documented permanent, persistent, or paroxysmal atrial fibrillation
CHA2DS2VASc risk of stroke ≥2
Disqualifiers
Serious mental diseases, particularly: dementia syndrome of any etiology, schizophrenia,schizoaffective disorders, bipolar disorder
History of ischemic stroke
Chronic abuse of alcohol or any other psychoactive substances except for nicotine
long-term therapy with benzodiazepines
Trial design
Treatments tested in this trial
- LAAC procedure with the use of transcatheter cerebral protection system
- LAAC procedure without the use of transcatheter cerebral protection system
Treatment groups
240 Participants
are divided into 2 treatment groupsSponsors and collaborators
Silesian Centre for Heart Diseases
Lead sponsor
Leszek Giec Upper-Silesian Medical Centre
Collaborator
Medical University of Silesia
Collaborator
Biostat Sp. z o.o.
Collaborator
Source ClinicalTrials.gov