Status:
RECRUITING
Cerebral Protection in Transcatheter Left Atrial Appendage Occlusion
Lead Sponsor:
Silesian Centre for Heart Diseases
Collaborating Sponsors:
Leszek Giec Upper-Silesian Medical Centre
Medical University of Silesia
Conditions:
Atrial Fibrillation
Silent Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 brai...
Detailed Description
Introduction: Left atrial appendage occlusion (LAAC) procedure is a method of preventing stroke in patients with atrial fibrillation who cannot use anticoagulants. The number of patients undergoing LA...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT05369195
Start Date
May 26 2023
End Date
September 1 2026
Last Update
September 28 2023
Active Locations (6)
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1
Górnośląskie Centrum Medyczne im. prof. Leszka Gieca Śląskiego Uniwesryeteu Medycznego
Katowice, Poland, 40-635
2
Klinika Chorób Serca i Naczyń, Krakowski Szpital Specjalistyczny im. Jana Pawła II
Krakow, Poland, 31-202
3
I Klinika Kardiologii Katedry Kardiologii UM im. Karola Marcinkowskiego w Poznaniu, Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu
Poznan, Poland, 61-848
4
Klinika Kardiologii i Chorób Wewnętrznych, Wojskowy Instytut Medyczny
Warsaw, Poland, 04-141