Atrial Fibrillation Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older
• People who have been diagnosed with atrial fibrillation (an irregular heartbeat condition) that is paroxysmal (comes and goes), persistent, or permanent, and is not caused by a heart valve problem
• People whose doctors have calculated a stroke risk score (called CHA2DS2-VASc) of 2 or more (for men) or 3 or more (for women), indicating a higher risk of stroke
• People for whom blood-thinning medication has been recommended, but where there is a reasonable medical reason to consider a non-medication alternative instead
• People whom both the procedural doctor and a separate independent clinician have agreed, through a shared decision-making process, are suitable for a procedure to close a small pouch in the heart called the left atrial appendage (LAA) — and where this agreement has been recorded in their medical file
• People who are willing and able to take required medications and attend follow-up appointments after the procedure
• People (or their legally authorised representative) who have been fully informed about the study and have signed a written consent form approved by an ethics committee

Who may not be able to join:

• People who are pregnant, breastfeeding, or planning to become pregnant during the study period; women of childbearing age must have a negative pregnancy test within 7 days before the procedure
• People whose atrial fibrillation occurred only once, or was temporary and caused by something treatable or reversible (such as heart bypass surgery, a medical procedure, pneumonia, or an overactive thyroid)
• People who need long-term blood-thinning medication for a reason other than atrial fibrillation
• People who have a condition that affects their blood's ability to clot properly
• People with rheumatic mitral valve disease, severe narrowing of the mitral heart valve, or an existing artificial (mechanical) heart valve
• People with an active blood infection (bacteremia)
• People with known allergies or medical reasons to avoid aspirin, clopidogrel, heparin, or any materials used in the device (including nickel titanium, certain plastics, or contrast dye used in imaging)
• People who have previously had surgical repair of a hole in the heart (ASD or PFO), or who have had a closure device implanted for this purpose
• People whose left atrial appendage has already been surgically removed or sealed off
• People who have had a heart or other surgical or interventional procedure within the 30 days before the procedure, or who have one planned within 60 days after the implant procedure (for example, cardioversion, ablation, heart stent, or even cataract surgery)
• People who have had a stroke, mini-stroke (TIA), or heart attack within the 90 days before the procedure
• People with the most severe category of heart failure (New York Heart Association Class IV)
• People with severely reduced kidney function (confirm with trial site for specific test values)
• People with significant narrowing of the carotid arteries (the arteries in the neck supplying the brain), based on specific thresholds — though people who have already had treatment for carotid artery disease with less than 50% narrowing remaining may still be considered (confirm with trial site)
• People with a life expectancy of less than one year
• People who are currently taking part in another clinical trial involving an experimental drug or medical device

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