Health Trials

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 groups

Locations

6
Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwesryeteu Medycznego40-635, Katowice Poland
Klinika Chorób Serca i Naczyń, Krakowski Szpital Specjalistyczny im. Jana Pawła II31-202, Krakow Poland
I Klinika Kardiologii Katedry Kardiologii UM im. Karola Marcinkowskiego w Poznaniu, Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu61-848, Poznan Poland
Klinika Choroby Wieńcowej i Strukturalnych Chorób Serca, Narodowy Instytut Kardiologii Stefana kardynała Wyszyńskiego - Państwowy Instytut Badawczy04-625, Warsaw Poland

Sponsors 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