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 heart rhythm that causes symptoms and has lasted a certain period of time)
• People whose doctor has chosen a procedure called pulmonary vein isolation (a type of heart ablation) to treat their irregular heart rhythm
• People who have already tried at least one heart rhythm medication that did not work, caused unbearable side effects, or was not suitable for them
• People aged between 18 and 75 years old
• People who are willing and able to give their informed consent to participate
• People who are able and willing to attend all required appointments and complete all testing before, during, and after the trial

Who may not be able to join:

• People whose atrial fibrillation has been continuous for more than 12 months (sometimes called longstanding persistent AF)
• People who have previously had a surgical or catheter-based procedure to treat atrial fibrillation
• People who have had any heart surgery, including a procedure to open blocked heart arteries (such as a stent), in the past 2 months
• People who have previously had heart bypass surgery combined with valve surgery or other major heart operations
• People who have had a procedure on the arteries in their neck (such as a stent or surgical cleaning of those arteries)
• People who have a blood clot in the upper left chamber of their heart
• People whose left heart chamber is severely enlarged (confirm with trial site for exact measurement)
• People whose heart pumping function is significantly reduced (below 40%, confirm with trial site)
• People with a known significant abnormality in the shape or structure of their pulmonary veins (the veins connecting the lungs to the heart) that the investigator believes would prevent participation
• People who have previously been diagnosed with narrowing of the pulmonary veins
• People who have a pre-existing condition where one side of the breathing muscle (diaphragm) is already partially paralysed
• People with a history of blood clotting disorders, abnormal bleeding, or who cannot safely take blood-thinning medications
• People who have had a heart attack in the past 2 months
• People who have had a blood clot travel to the brain or elsewhere in the body (including a mini-stroke) within the past 6 months
• People who have rheumatic heart disease
• People whose heart failure is not controlled, or whose heart failure is classified as severe (New York Heart Association class III or IV)
• People with severe leaking of the main heart valve (mitral valve)
• People expected to need a heart transplant, heart surgery, or other major surgery within the next 12 months
• People who have had unstable chest pain (angina) within the past 6 months
• People who currently have an acute illness, active infection, or blood poisoning (sepsis)
• People whose atrial fibrillation is known to be caused by something else, such as a thyroid condition, electrolyte imbalance, severe obesity (BMI over 40), sleep apnoea, significant kidney problems, or alcohol use
• People who have a blood clot, tumour, patch, artificial valve, or other abnormality inside the heart that would make it unsafe to pass a catheter (a thin flexible tube) through
• People who have a blood clot, tumour, or other abnormality in the blood vessels that would prevent safe access for the procedure
• People who have any other condition that prevents safe access to the blood vessels needed for the procedure (such as a filter placed in a large vein in the abdomen)
• People with significant lung disease or any ongoing lung condition that causes persistent symptoms
• People with a significant inborn (congenital) abnormality or other medical condition that the investigator believes would prevent safe participation
• Women who are pregnant, breastfeeding, or of childbearing age and planning to become pregnant during the trial
• People currently taking part in another clinical trial involving an experimental device, biological treatment, or medication
• People for whom the devices used in this trial are not recommended, based on the manufacturer's instructions
• People who are considered a vulnerable population requiring special protections (confirm with trial site)
• People with a life expectancy of less than 12 months
• People for whom an MRI scan is not safe, such as those with a pacemaker, implanted heart device (ICD), severe kidney disease preventing the use of contrast dye, or claustrophobia (confirm with trial site, as this is assessed case by case)
• People who have metal fragments containing iron anywhere in their body
• People with an existing neurological problem (such as a deficit affecting movement or sensation) that has not been resolved

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