Atrial Fibrillation Trial, Recruiting NCT05369195 Sponsor: Silesian Centre for Heart Diseases Condition: Atrial Fibrillation
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Atrial Fibrillation Trial, Recruiting

NCT05369195
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 years or older
  • People who are able to read, understand, and sign a consent form agreeing to take part
  • People who have been diagnosed with atrial fibrillation (an irregular heartbeat), whether it is permanent, long-lasting, or comes and goes
  • People whose stroke risk score (called CHA2DS2VASc) is 2 or higher, as calculated by their doctor
  • People who either have a medical reason they cannot take blood thinners, or whose bleeding risk score (called HAS-BLED) is 3 or higher

Who may not be able to join:

  • People with serious mental health conditions, including dementia (of any cause), schizophrenia, schizoaffective disorder, or bipolar disorder
  • People who have previously had an ischemic stroke (a stroke caused by a blood clot)
  • People with a history of long-term heavy use of alcohol or other mind-altering substances (not including nicotine)
  • People who are on long-term treatment with a type of medication called benzodiazepines (used for anxiety or sleep)
  • People who have taken antidepressant medications within the 3 months before joining the trial
  • People who have had a past infection of the brain or nervous system, including a condition called neuroborreliosis (a nervous system infection caused by tick bites)
  • People diagnosed with Parkinson's disease
  • People diagnosed with Huntington's disease
  • People diagnosed with Creutzfeldt-Jakob disease
  • People diagnosed with Pick's disease (a type of brain condition)
  • People who have significant narrowing (more than 70%) in certain major arteries supplying the brain (confirm with trial site)
  • People who have abnormalities such as narrowing, widening, tearing, or bulging in certain large arteries near the heart (confirm with trial site)
  • People whose brain MRI shows advanced changes to blood vessels, rated at the highest level (grade 3) on a standard medical scale
  • People who have a blood clot or tumour in the left upper chamber of the heart or its attached pouch
  • People who have a blood clot in the left lower chamber of the heart
  • People whose heart anatomy makes it not possible to use a closure device in a particular part of the heart (confirm with trial site)
  • People who have a mechanical (man-made) heart valve
  • People who have previously had open surgery to close a hole between the upper chambers of the heart
  • People who have previously had a closure device used to seal a hole between the upper chambers of the heart
  • People who currently have an active heart infection (infective endocarditis)
  • People who have implanted devices or prostheses that are not safe for MRI scans, such as certain pacemakers or surgical clips in the brain
  • People who have had surgery on their oesophagus (the tube connecting the throat to the stomach)
  • People who have pouches or pockets in the wall of the oesophagus
  • People who have enlarged veins in the oesophagus rated above grade 3
  • People who are allergic to contrast dye used in medical scans
  • People who have a medical reason they cannot take antiplatelet medications (a type of blood-thinning tablet)
  • People who have been diagnosed with cancer and whose estimated survival is less than one year (confirm with trial site)
  • People with a clinically confirmed underactive or overactive thyroid gland
  • People who experience claustrophobia (fear of enclosed spaces, such as an MRI machine)
  • People who are pregnant
  • People diagnosed with AIDS
  • People already taking part in another clinical drug trial
  • People whom the trial doctor considers unsuitable for any other medical or personal reason

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 12 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Zbigniew F Kalarus, Prof., Silesian Centre for Heart Diseases in Zabrze

Phone: 0048322713414

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Silesian Centre for Heart Diseases
Registry
ClinicalTrials.gov
Start date
26 May 2023
Est. completion
31 December 2025

Where this trial is recruiting

🇵🇱 Poland

Primary endpoints

Change in number of silent cerebral ischemia (SBI) foci; Change in volume of silent cerebral ischemia (SBI) foci

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 12 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov