Actively Recruiting
Led by Silesian Centre for Heart Diseases · Updated on 2023-09-28
240
Participants Needed
6
Research Sites
34 weeks
Total Duration
S
Silesian Centre for Heart Diseases
Lead Sponsor
L
Leszek Giec Upper-Silesian Medical Centre
Collaborating Sponsor
Researchers are evaluating the use of neuroprotection during the transcutaneous occlusion of the left atrial appendage (LAAC) in patients with atrial fibrillation. This study aims to see if neuroprotection can reduce the risk of silent brain ischemia (SBI) that sometimes occurs around the time of the procedure and may lead to cognitive decline, dementia, or depression. The trial is a prospective, multicenter, randomized, and double-blind intervention study including 240 patients who need stroke prevention and cannot use anticoagulants. Participants are randomly assigned to one of two groups: one receiving LAAC with a transcatheter cerebral protection system delivered through radial artery access before the procedure, and the other undergoing LAAC without the neuroprotection device. Both groups have the LAAC procedure, but only the study group uses the cerebral protection system. The study will follow patients for 24 months after the procedure to monitor outcomes. During the study, patients will undergo brain MRI scans, neurological exams, and cognitive and mood assessments at several time points before and up to two years after the procedure. Researchers will measure changes in silent cerebral ischemia focus number and volume, cognitive function tests, dementia development, depression symptoms, and quality of life. The study also monitors the presence of embolic material caught by the neuroprotection device during the procedure. Safety and long-term outcomes will be closely followed throughout the study period.
CONDITIONS
Cerebral Protection in Transcatheter Left Atrial Appendage Occlusion
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day (procedure day)
Participants undergo the left atrial appendage closure (LAAC) procedure, with or without a transcatheter cerebral protection system, to reduce the risk of stroke associated with atrial fibrillation.
1 treatment visit (in-person)
Duration - Up to 24 months after the procedure
Participants are monitored and evaluated for cognitive function, mood disorders, and brain imaging changes following the LAAC procedure to assess outcomes over time.
Visits at discharge (up to 5 days), 90 days, 12 months, and 24 months (in-person)
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
W
Witold A Streb, Ph.D.
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Witold Streb, Anetta Lasek-Bal, Katarzyna Mitręga...
https://pubmed.ncbi.nlm.nih.gov/37996955