RecruitingNot Applicable

Cerebral Protection in Transcatheter Left Atrial Appendage Occlusion

Poland240 participantsStarted 2023-05-26

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Change in number of silent cerebral ischemia (SBI) foci

Timeframe: change in the period up to 24 months

Change in volume of silent cerebral ischemia (SBI) foci

Timeframe: change in the period up to 24 months

Trial details

NCT IDNCT05369195

SponsorSilesian Centre for Heart Diseases

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

Contact for this trial

Witold A Streb, Ph.D.

0048322713414 w.streb@sccs.pl

View on ClinicalTrials.gov More Atrial Fibrillation trials