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:

• People who have been diagnosed with symptomatic persistent atrial fibrillation (an irregular heartbeat that has continued non-stop for more than 7 days but less than 365 days), confirmed by a doctor's notes and at least two heart tracings (ECGs) taken at least 7 days apart, or a 24-hour heart monitor recording, all within the past 365 days
• People who are between 18 and 80 years of age at the time of signing the consent form
• People who are willing and able to give informed consent to take part in the study
• People who are able and willing to attend and complete all required appointments and tests before, during, and after the trial

Who may not be able to join:

• People whose atrial fibrillation has been continuous for more than 365 days
• People whose atrial fibrillation is caused by a treatable or non-heart-related condition, such as a thyroid problem, electrolyte imbalance, untreated sleep apnoea, or alcohol-related causes
• People who have previously had a surgical or catheter-based procedure to treat atrial fibrillation
• People who are known to need a heart procedure in areas of the heart beyond specific regions that the trial targets (confirm with trial site)
• People whose left upper heart chamber (left atrium) is severely enlarged, based on imaging done within the past 180 days
• People found to have a blood clot in their heart on imaging taken within 48 hours before the procedure
• People whose heart's main pumping chamber has severely reduced function (less than 40% efficiency), confirmed by imaging within the past 180 days
• People with uncontrolled heart failure or heart failure that severely limits physical activity or causes symptoms at rest
• People with a history of blood clotting disorders, abnormal bleeding, or who cannot safely take blood-thinning medication
• People who have had a stroke, mini-stroke (TIA), or other blood clot event within the past 180 days
• People who have had a heart attack or a procedure to open blocked heart arteries within the past 60 days
• People who have had open-heart bypass surgery within the past 180 days
• People who have had surgery or a procedure on a heart valve, or who have an artificial heart valve
• People who have had unstable chest pain (angina) within the past 6 months
• People who are expected to need a heart transplant, heart surgery, or other major surgery within 365 days after the procedure
• People with significant lung disease or other serious ongoing lung or breathing problems
• People with significant heart or structural abnormalities present from birth, including those that have been repaired, that the investigator considers would prevent safe participation
• People who already have a diagnosis of narrowing of the pulmonary veins (the blood vessels connecting the lungs to the heart)
• People who already have paralysis of one side of the diaphragm (the breathing muscle)
• People who currently have an acute illness, active infection, or blood poisoning (sepsis)
• People who have a blood clot, tumour, abnormal growth, or other structural problem inside the heart that would prevent safe use of the procedure's equipment
• People with a severe leaking mitral heart valve, as defined by specific measurements (confirm with trial site)
• People who have certain types of implanted metal heart devices that may interfere with the energy used in this procedure (coronary stents, pacemakers, defibrillators, and implantable loop recorders are not included in this restriction — confirm with trial site)
• People who have a condition that prevents access to the required blood vessels, such as a filter placed in the large vein leading to the heart
• People who are currently participating in another clinical study involving an investigational device or drug
• People who are pregnant, breastfeeding, or of childbearing potential and planning to try to become pregnant during the trial
• People whose life expectancy is less than 365 days

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