Cerebral Protection in Transcatheter Left Atrial Appendage Occlusion
Recruiting · NCT05369195 · Interventional (participants receive a specific treatment) · Lead sponsor: Silesian Centre for Heart Diseases
View the official record on ClinicalTrials.gov →Interventions studied
LAAC procedure with the use of transcatheter cerebral protection systemLAAC procedure without the use of transcatheter cerebral protection system
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 18 Years and older
- Subject able to provide signed informed consent.
- Documented permanent, persistent, or paroxysmal atrial fibrillation
- CHA2DS2VASc risk of stroke ≥2
- At least one of the following criteria:
- Contraindications to the use of anticoagulants,
- HSBLED bleeding risk ≥3
Exclusion criteria
- 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
- The use of antidepressants in 3 months prior inclusion.
- Previous infections of the central nervous system, including neuroborreliosis
- Parkinson's disease
- Huntington's chorea
- Creutzfeld-Jakob disease
- Pick's disease
- Significant atherosclerosis of the cephalic arteries (\> 70% LCCA or the brachiocephalic trunk)
- Strictures, ectasias, dissection or aneurysms at the exit of the LCCA or the brachiocephalic trunk from the aorta and up to 3 cm above
- Advancement of vascular changes in DW MRI of the head, grade 3 on the Fazekas scale
- Presence of a thrombus or tumours of a different nature in the left atrium or its ear
- Presence of a thrombus in the left ventricle
- Left atrial appendage anatomy preventing the use of occluders to close the left atrium appendage
- The presence of mechanical heart valve prostheses
- The state after the operative closure of the defect in the atrial septum
- Condition after closing the defect in the interatrial septum with the use of occluders
- Active infective endocarditis
- Presence of devices and prostheses that prevent the performance of MRI (pacemakers, clips in the CNS)
- Status after oesophagal surgery
- Esophageal diverticula
- Esophageal varices\> grade 3
- Allergic to contrast agents
- A contraindication to use antiplatelet drugs
- Diagnosis of neoplastic disease with estimated survival beyond 1 year
- Clininally evident hypothyroidism and hyperthyroidism
- Klaustrofobia
- Pregnancy
- AIDS
- Participation in other drug research studies
- The presence of circumstances or any medical condition the Investigator considers problematic for subject inclusion, or test results that may couse problems to provide reliable, acurate to interpretation results
Where it is running
6 locations listed.
- Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwesryeteu Medycznego - Katowice, Poland
- Klinika Chorób Serca i Naczyń, Krakowski Szpital Specjalistyczny im. Jana Pawła II - Krakow, Poland
- I Klinika Kardiologii Katedry Kardiologii UM im. Karola Marcinkowskiego w Poznaniu, Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu - Poznan, Poland
- Klinika Kardiologii i Chorób Wewnętrznych, Wojskowy Instytut Medyczny - Warsaw, Poland
- Klinika Choroby Wieńcowej i Strukturalnych Chorób Serca, Narodowy Instytut Kardiologii Stefana kardynała Wyszyńskiego - Państwowy Instytut Badawczy - Warsaw, Poland
- Silesian Centre for HEart Diseases in Zabrze - Zabrze, Poland