Stroke 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:

• People who are 18 years of age or older at the time of screening
• People who have been diagnosed with a type of irregular heartbeat called atrial fibrillation (AF) that is not caused by a faulty heart valve
• People who have a medical reason to have a procedure to close off a small pouch in the heart called the left atrial appendage (LAA)
• People who are willing and able to attend all scheduled follow-up visits and complete required testing throughout the trial
• People who are willing and able to give written consent to participate

Who may not be able to join:

• People who have had moderate to severe heart failure symptoms in the 30 days before the procedure
• People who have a known bleeding disorder, a low platelet count, severe anaemia, or blood that does not clot normally — assessed within 30 days before the procedure
• People who have had a heart attack or severe chest pain (unstable angina) within 90 days before the procedure
• People who have had a stroke, mini-stroke (TIA), or suspected neurological event within 90 days before the procedure
• People with severely reduced kidney function or end-stage kidney disease
• People who need to take blood-thinning medication long-term for a reason other than AF
• People with an active infection, blood poisoning, inflammation around the heart, or unexplained fever
• People with a known tendency to form blood clots due to a medical or inherited condition, confirmed by prior testing
• People who cannot take the standard blood-thinning medications required after the procedure
• People with rheumatic heart disease
• People who have an artificial mechanical heart valve
• People with significant narrowing of the carotid arteries (the blood vessels in the neck) as defined by specific measurements
• People with a body mass index (BMI) greater than 40
• People who are pregnant, breastfeeding, or planning to become pregnant within 12 months after the procedure
• People who are already enrolled in, or planning to join, another trial that would interfere with this study
• People with a mental health condition that may prevent them from fully understanding what the study involves
• People considered unsuitable by the lead doctor at the trial site for any other health or medical reason
• People with a known allergy or sensitivity to nitinol (a metal made of nickel and titanium) or any other materials used in the device being studied
• People with a life expectancy of less than one year
• People who are unable or unwilling to undergo certain heart imaging procedures (such as a heart ultrasound or CT scan) or the catheter-based procedure required in this trial
• People whose heart anatomy means the device cannot be safely used, as determined by the lead doctor
• People whose pre-procedure CT scan shows that the opening of the LAA is either too large (greater than 25 mm) or too small (less than 17 mm) for the device
• People whose CT scan results suggest the device may not be suitable (confirm with trial site)
• People who have a blood clot inside the heart, detected by CT scan or ultrasound
• People who have previously had their LAA closed or tied off by any surgical or non-surgical method
• People who already have an implanted device used to close a hole in the heart (such as for a heart wall defect)
• People whose heart pumping function is severely reduced, with a measurement called left ventricular ejection fraction (LVEF) below 30%

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