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 recurring paroxysmal atrial fibrillation (a type of irregular heartbeat that comes and goes), where episodes last more than 30 seconds but stop on their own or with treatment within 7 days, with at least 2 symptomatic episodes recorded by a doctor in the 6 months before joining, and at least 1 episode confirmed by a heart tracing (ECG) in the 12 months before joining.
• People aged 18 to 80 years old on the day they enrol in the trial.
• People who are willing and able to attend all required check-ups and follow-up visits for the full length of the study.

Who may not be able to join:

• People whose irregular heartbeat has continued without stopping for more than 7 days, or who have been diagnosed with persistent atrial fibrillation.
• People who have needed three or more electrical shock treatments (cardioversions) to restore their heart rhythm in the past 12 months.
• People whose left atrial chamber of the heart measures more than 5.0 cm (as measured by MRI, CT scan, or ultrasound).
• People who have previously had a catheter-based or surgical procedure on the left side of the heart, or devices such as a left atrial appendage closure device or a hole-in-the-heart closure device.
• People who have a plan to have a heart closure procedure, or to have a permanent pacemaker, defibrillator, or implanted heart monitor placed at any point during the study follow-up period.
• People who have not been taking blood thinning tablets (oral anticoagulation) for at least 3 weeks before the procedure.
• People who already have a pacemaker, defibrillator, or implanted heart monitor in place.
• People who have stents (small mesh tubes) inside their pulmonary veins (the blood vessels connecting the lungs to the heart).
• People who already have a known narrowing of the pulmonary veins.
• People who have existing paralysis of one side of their diaphragm (the muscle used for breathing).
• People who have previously had heart valve surgery or a valve procedure of any kind, or surgery that involved opening one of the heart's upper chambers.
• People with moderate to severe narrowing of the aortic or mitral heart valves.
• People with moderate to severe leakage of the mitral heart valve.
• People who have had heart surgery, a heart attack, a procedure to open blocked heart arteries, or a coronary artery stent placed within the 3 months before consenting to join the trial.
• People with unstable chest pain (unstable angina).
• People with severe heart failure (classified as NYHA Class III or IV), or whose heart pumping function is measured at 40% or below, or who are being considered for a heart transplant or mechanical heart pump.
• People with serious lung disease, high blood pressure in the lungs, abnormal blood oxygen levels, or who need supplemental oxygen.
• People with rheumatic heart disease.
• People with severely abnormal platelet counts or any bleeding or clotting disorder.
• People who are unable or unwilling to take blood-thinning medication.
• People who have a blood clot in the left upper chamber of their heart, confirmed by imaging.
• People with an active infection or sepsis (a severe body-wide infection response).
• People with hypertrophic cardiomyopathy (a condition where the heart muscle is abnormally thick).
• People whose atrial fibrillation is caused by a known, treatable condition such as an overactive thyroid, severe untreated sleep apnoea, or recent excessive alcohol use.
• People who have had a stroke or mini-stroke (TIA) in the 6 months before consenting to join the trial.
• People who have had a procedure on the carotid arteries (the main arteries in the neck), such as a stent or surgical cleaning of the artery.
• People who have had a blood clot event in the past 6 months, or in whom a clot inside the heart is found at the time of the procedure.
• Women who are pregnant, breastfeeding, or of childbearing age who are not using a reliable method of contraception or abstinence.
• People whose general health or life expectancy makes it unlikely they would complete 12 months of follow-up.
• People already participating, or planning to participate, in another clinical trial of a drug, device, or biological treatment during this study, unless pre-approved by the study sponsor (Medtronic).
• People with known allergies or sensitivities to adhesives.
• People with a body mass index (a measure of body weight relative to height) above 40.
• People with a benign heart tumour called an atrial myxoma.
• People with significant long-term lung or breathing conditions.
• People with poor kidney function (eGFR below 30 mL/min/1.73 m²), or a history of kidney failure requiring dialysis or a kidney transplant.
• People who have received a solid organ or bone marrow transplant, or who are currently being assessed for one.
• People with a blood clot, tumour, or other abnormality inside the body that would prevent safe access for the procedure's catheter (a thin tube used during the procedure).
• People with a known dependency on drugs or alcohol.
• People with a significant inborn heart or body abnormality that, in the opinion of the study doctor, would prevent safe participation or affect the reliability of the study results (confirm with trial site).
• People who have been treated with the heart medication amiodarone within 3 months before enrolling.
• People with amyloid heart disease (a condition where abnormal proteins build up in the heart muscle).

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