Actively Recruiting
Cerebral Protection in Transcatheter Left Atrial Appendage Occlusion
Led by Silesian Centre for Heart Diseases · Updated on 2023-09-28
240
Participants Needed
6
Research Sites
170 weeks
Total Duration
On this page
Sponsors
S
Silesian Centre for Heart Diseases
Lead Sponsor
L
Leszek Giec Upper-Silesian Medical Centre
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Cerebral Protection in Transcatheter Left Atrial Appendage Occlusion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years and older
- Able to provide signed informed consent
- Documented permanent, persistent, or paroxysmal atrial fibrillation
- CHA2DS2VASc stroke risk score of 2 or higher
- At least one of the following: contraindications to anticoagulants or HAS-BLED bleeding risk score of 3 or higher
You will not qualify if you...
- Serious mental diseases such as dementia, schizophrenia, schizoaffective disorders, or bipolar disorder
- History of ischemic stroke
- Chronic abuse of alcohol or other psychoactive substances except nicotine
- Long-term benzodiazepine therapy
- Use of antidepressants within 3 months before inclusion
- Previous central nervous system infections including neuroborreliosis
- Parkinson's disease
- Huntington's chorea
- Creutzfeld-Jakob disease
- Pick's disease
- Significant atherosclerosis (>70%) of cephalic arteries (LCCA or brachiocephalic trunk)
- Strictures, ectasias, dissection, or aneurysms in LCCA or brachiocephalic trunk near the aorta
- Advanced vascular changes on DW MRI of the head (grade 3 Fazekas scale)
- Presence of thrombus or tumors in left atrium or left ventricle
- Left atrial appendage anatomy unsuitable for occluder use
- Mechanical heart valve prostheses
- Previous surgical closure of atrial septal defects
- Active infective endocarditis
- Devices or prostheses preventing MRI (e.g., pacemakers, CNS clips)
- History of oesophageal surgery, diverticula, or grade >3 varices
- Allergy to contrast agents
- Contraindication to antiplatelet drugs
- Diagnosed neoplastic disease with survival beyond 1 year
- Clinically evident hypo- or hyperthyroidism
- Claustrophobia
- Pregnancy
- AIDS
- Participation in other drug research studies
- Any condition the investigator considers problematic for inclusion or reliable results
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwesryeteu Medycznego
Katowice, Poland, 40-635
Not Yet Recruiting
2
Klinika Chorób Serca i Naczyń, Krakowski Szpital Specjalistyczny im. Jana Pawła II
Krakow, Poland, 31-202
Not Yet Recruiting
3
I Klinika Kardiologii Katedry Kardiologii UM im. Karola Marcinkowskiego w Poznaniu, Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu
Poznan, Poland, 61-848
Not Yet Recruiting
4
Klinika Kardiologii i Chorób Wewnętrznych, Wojskowy Instytut Medyczny
Warsaw, Poland, 04-141
Not Yet Recruiting
5
Klinika Choroby Wieńcowej i Strukturalnych Chorób Serca, Narodowy Instytut Kardiologii Stefana kardynała Wyszyńskiego - Państwowy Instytut Badawczy
Warsaw, Poland, 04-625
Not Yet Recruiting
6
Silesian Centre for HEart Diseases in Zabrze
Zabrze, Poland, 41-800
Actively Recruiting
Research Team
W
Witold A Streb, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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