Atrial Fibrillation Trial, Recruiting

Written by an AI model from the 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 had exactly one previous ablation procedure for atrial fibrillation (AF) in the past 3 years
• People whose AF, or a related heart rhythm problem, came back at least 90 days after their first ablation, with a doctor's note confirming at least one symptomatic episode in the past 12 months and at least one episode confirmed by a heart tracing (such as an ECG) in the past 12 months
• Adults aged 18 or older at the time of enrolment
• People who are willing and able to follow all study requirements and sign a consent form

Who may not be able to join:

• People who have had continuous AF lasting 12 months or longer
• People whose heart's upper-left chamber (left atrium) is above a certain size, as measured by medical imaging — the specific size limit depends on the type of AF (confirm with trial site)
• People who have previously had certain procedures on the left side of the heart, such as a left atrial appendage closure or a hole-in-the-heart repair device
• People who have a planned heart procedure during the follow-up period, such as a heart transplant, pacemaker implant, or implantable defibrillator
• People who have had more than one previous AF ablation procedure
• People who have had any previous surgical ablation procedure
• People who have not been taking blood-thinning medication (anticoagulants) for at least 3 weeks before the ablation
• People who cannot take or are unwilling to use blood-thinning medication
• People with serious blood clotting or bleeding disorders, or abnormal platelet counts
• People who already have a pacemaker, implantable defibrillator, or insertable heart monitor
• People who have stents in their pulmonary veins (blood vessels connecting the lungs to the heart)
• People with a known narrowing of the pulmonary veins
• People with pre-existing paralysis of one side of the diaphragm (the muscle used for breathing)
• People who have had any previous heart valve procedure or surgery inside the heart chambers
• People with moderate to severe narrowing of the mitral or aortic heart valves
• People with moderate to severe leaking of the mitral heart valve
• People who have had heart surgery, a heart attack, or a procedure to open blocked heart arteries within the past 3 months
• People with more advanced heart failure (classified as NYHA Class III or IV — confirm with trial site)
• People whose heart pumping function is at or below 40%, as measured by cardiac testing
• People with unstable chest pain (unstable angina)
• People with severe lung disease, high blood pressure in the lung arteries, or any lung condition requiring oxygen support
• People with rheumatic heart disease
• People with significant chronic lung or breathing conditions
• People found to have a blood clot in the left atrium on imaging
• People with an active infection or sepsis
• People with hypertrophic cardiomyopathy (a thickened heart muscle condition)
• People with amyloid heart disease
• People with a diagnosed benign heart tumour called an atrial myxoma
• People whose AF is caused by a known, treatable condition, such as uncontrolled thyroid disease or severe untreated sleep apnea
• People who have had a stroke or mini-stroke (TIA) in the past 6 months
• People who have had carotid artery stenting or surgery
• People who have had a blood clot event in the past 6 months, or who have a clot detected in the heart at the time of the procedure
• People with a body mass index (BMI) above 40
• People who are known to be pregnant or breastfeeding, or people of childbearing potential who are not using a reliable form of contraception or abstinence
• People whose life expectancy makes it unlikely they will complete 12 months of follow-up
• People currently participating in another clinical study of a drug, device, or biological treatment not pre-approved by the study sponsor (Medtronic)
• People with significant kidney problems (eGFR below 30), or a history of kidney failure requiring dialysis or a kidney transplant
• People with a clot, tumour, or other abnormality that would make catheter access or movement unsafe
• People with a certain type of filter device in a major vein (inferior vena cava filter) that could make the procedure unsafe
• People with a known dependency on drugs or alcohol
• People with a significant birth defect or medical condition that, in the investigator's opinion, would prevent safe participation or affect the study's reliability

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