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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
LAAC procedure with the use of transcatheter cerebral protection system
Procedure/SurgeryAfter aortography the cerebral protection system will be delivered to cerebral arteries through radial access before accessing the left atrium.
LAAC procedure without the use of transcatheter cerebral protection system
Procedure/SurgeryOnly the aortography through radial access will be done before accessing the left atrium.
Treatment groups
240 Participants
are divided into 2 treatment groupsGroup A: LAAC with neuroprotectionExperimental treatment 1 intervention
Group B: LAAC without neuroprotectionPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in number of silent cerebral ischemia (SBI) foci
number of SBI foci in DW MRI of the brain
Time frame
change in the period up to 24 months2
Change in volume of silent cerebral ischemia (SBI) foci
volume SBI foci in DW MRI of the brain
Time frame
change in the period up to 24 monthsSecondary outcomes
1
Deterioration of cognitive functions
Montreal Cognitive Assessment (MoCA) test (scoring 0-30; cut-off value \<26)
Time frame
prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 months2
Deterioration of cognitive functions
The Trail Making Test Part A and B for Dementia (TMT A\&B) - incorrect values: for part A \> 70 sec. and for part B\> 273 sec.
Time frame
prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 months3
Development of dementia
diagnosis made by a specialist neurologist
Time frame
prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 months4
Occurrence of depressive disorders
Hemiltona depression scale - 0 to 50 point, the higher the score, the more severe the mood disorder
Time frame
prior to procedure, discharge (up to 5 days), 90 days, 12 months, 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
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