RecruitingNot ApplicableNCT05369195

Cerebral Protection in Transcatheter Left Atrial Appendage Occlusion

Cerebral Protection in Transcatheter Left Atrial Appendage Occlusion in Patients With Atrial Fibrillation


Sponsor

Silesian Centre for Heart Diseases

Enrollment

240 participants

Start Date

May 26, 2023

Study Type

INTERVENTIONAL

Conditions

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 brain ischemia and associated cognitive impairment and depression.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether using a cerebral protection device during a heart procedure called left atrial appendage occlusion (LAAO) — a procedure that closes off a small pouch in the heart to prevent stroke in people with atrial fibrillation — reduces the risk of small strokes or brain damage caused by debris released during the procedure. **You may be eligible if...** - You are 18 or older - You have atrial fibrillation (an irregular heart rhythm) - Your stroke risk score (CHA2DS2-VASc) is 2 or above - You cannot take blood thinners safely or have a high bleeding risk **You may NOT be eligible if...** - You have a history of stroke caused by a clot - You have serious mental illness such as dementia or schizophrenia - You have a blood clot in the heart - You have Parkinson's disease, Huntington's disease, or other neurological conditions - You are pregnant - You have HIV/AIDS - You have severe narrowing of the arteries supplying your brain - You have a pacemaker or metal in your body preventing MRI Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURELAAC procedure with the use of transcatheter cerebral protection system

After aortography the cerebral protection system will be delivered to cerebral arteries through radial access before accessing the left atrium.

PROCEDURELAAC procedure without the use of transcatheter cerebral protection system

Only the aortography through radial access will be done before accessing the left atrium.


Locations(6)

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

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NCT05369195


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