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 who are male or not currently pregnant
• People who have been diagnosed with a type of irregular heartbeat called atrial fibrillation (AF), whether it comes and goes, has lasted a long time, or is permanent
• People whose doctors have calculated their stroke risk score (called CHA2DS2-VASc) to be 3 or higher, meaning they have a high risk of stroke or blood clots
• People who have a medical reason why a long-term blood-thinning medication may not be the best option for them
• People whose doctor considers them able to take blood-thinning medication for a short period, but not suitable for taking it long-term
• People whose medical team — including a doctor not involved in performing the procedure — has agreed, through a shared decision-making process, that a small device implanted in the heart to close off the left atrial appendage (a small pouch in the heart) is appropriate
• People who are able to follow the medication plan and attend all required check-up appointments as set out in the study
• People (or their legally authorised representative, where permitted) who have been fully informed about the study and have given written consent to take part

Who may not be able to join:

• People who are pregnant, breastfeeding, or planning to become pregnant within one year after the procedure; women who could potentially become pregnant must have a negative pregnancy test within 7 days before the procedure
• People whose heart anatomy would make the implant procedure impossible — for example, certain structural heart conditions or previous heart repairs that would interfere with the procedure (confirm with trial site)
• People whose atrial fibrillation was a single episode only, or was caused by a temporary or reversible condition such as a thyroid problem, alcohol intoxication, injury, or recent major surgery
• People who need to take long-term blood-thinning medication for a reason other than atrial fibrillation, such as a history of unprovoked blood clots in the legs or lungs, or a mechanical artificial heart valve
• People who have a history of serious bleeding problems or clotting disorders, or for whom blood-thinning or anti-clotting medications are not safe to use
• People who currently have an active infection anywhere in the body
• People who have significant narrowing of the carotid arteries (the main blood vessels in the neck) that is causing symptoms, unless a previous treatment has reduced the narrowing to below 50%
• People who have had, or are planning to have, another heart procedure or major surgery within 30 days before or 60 days after this procedure
• People who have had a stroke or mini-stroke (TIA) within the past 30 days
• People who have had a heart attack within the past 30 days
• People whose blood vessels cannot support the catheter-based delivery system used in the procedure
• People with very severe heart failure (the most serious category, known as Class IV)
• People who have had a heart transplant, mitral valve replacement, a transcatheter mitral valve procedure, or any mechanical artificial heart valve
• People with significantly reduced kidney function, as measured by a specific kidney test result below a set threshold (confirm with trial site)
• People whose blood platelet count or white blood cell count falls outside the ranges required by the study
• People who have a known allergy or serious reaction to aspirin, heparin, certain other blood-thinning medications, or to materials used in the device such as nickel or titanium, or who have a contrast dye sensitivity that cannot be managed with pre-medication
• People who are already enrolled in, or planning to join, another clinical study whose treatment may affect the results of this trial
• People who are unable to have general anaesthesia
• People with another serious medical condition, or a history of substance misuse, that may affect their ability to follow the study requirements, affect the results, or whose life expectancy is less than 5 years
• People for whom a specific type of heart imaging called a transesophageal echocardiogram (a camera passed down the throat to look at the heart) cannot be performed adequately

Additional heart imaging criteria that may prevent joining:

• People whose left atrial appendage shape or size is not suitable for either the study device or a commercially available device of the same type (confirm with trial site)
• People found to have a blood clot or signs of a likely clot inside the heart, as seen on imaging
• People whose heart pumping strength (ejection fraction) is below 30%
• People who have a moderate or large fluid collection around the heart, symptoms of heart sac inflammation, or signs of dangerous pressure around the heart
• People who have a hole between the upper chambers of the heart that needs to be closed
• People who have a specific type of high-risk hole in the heart wall involving significant movement of the heart wall or a large amount of blood passing through
• People with moderate or severe narrowing of the mitral valve (a valve inside the heart)
• People with complex fatty deposits or moving plaques in the main artery leaving the heart (the aorta)
• People with evidence of a tumour in the heart

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