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 is ongoing) or paroxysmal atrial fibrillation (an irregular heartbeat that comes and goes)
• People whose doctor has chosen a specific heart procedure called pulmonary vein isolation (a procedure to correct the irregular heartbeat), either on its own or combined with a related procedure for a particular type of flutter
• People who have already tried at least one heart rhythm medication that either did not work, caused unbearable side effects, or was not safe for them to take
• People aged 18 to 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
• 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) within the past 2 months
• People who have previously had coronary artery bypass surgery combined with heart valve surgery or other major heart surgery
• People who have had a procedure to treat a blocked neck artery (carotid stenting or endarterectomy)
• 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 specific measurements)
• People whose heart's pumping function is severely reduced (below 40%)
• People with a known significant abnormality in the shape or structure of their pulmonary veins (the blood vessels connecting the lungs to the heart) that, in the doctor's opinion, would prevent participation
• People who have previously been diagnosed with narrowing of the pulmonary veins
• People who already have paralysis of one side of the diaphragm (the muscle used for breathing)
• People with a history of blood clotting or bleeding disorders, or who cannot safely take blood-thinning medications
• People who have had a heart attack within the past 2 months
• People who have had a stroke, mini-stroke, or other blood clot-related event within the past 6 months
• People with rheumatic heart disease
• People with heart failure that is not well controlled, or who have been classified as having severe heart failure symptoms (NYHA class III or IV)
• People with severe leaking of the heart's mitral valve
• People who are expected to need a heart transplant, heart surgery, or other major surgery within the next 12 months
• People who have had unstable chest pain within the past 6 months
• People who are currently experiencing an acute illness, active infection, or sepsis (a serious whole-body response to infection)
• People whose atrial fibrillation is known to have been caused by a treatable or non-heart-related condition, such as a thyroid problem, electrolyte imbalance, severe sleep apnoea, acute alcohol toxicity, severe obesity, or significant kidney disease
• People who have a blood clot, tumour, abnormal tissue, or artificial heart valve inside the heart that would prevent the procedure from being safely performed
• 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 required blood vessels (such as a filter placed in a major vein)
• People with significant lung disease or any other ongoing lung or breathing condition causing persistent symptoms
• People with a significant birth defect or medical condition that, in the doctor's opinion, would prevent participation
• Women who are pregnant, breastfeeding, or of childbearing age and planning to become pregnant during the trial
• People who are currently taking part in another clinical trial involving a different medical device, biological treatment, or drug
• People for whom the devices used in this study are not suitable, based on the manufacturer's guidelines
• 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 who are unable to have an MRI scan for any reason, such as severe kidney disease preventing the use of contrast dye, claustrophobia, or having a pacemaker or implanted heart device (at the doctor's discretion)
• People who have iron-containing metal fragments anywhere in their body
• People who have an existing unresolved neurological condition (such as a nerve or brain-related deficit)

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