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, drug-resistant paroxysmal atrial fibrillation (a type of irregular heartbeat that starts and stops on its own or with treatment within 7 days), with at least two episodes recorded by a doctor in the past 6 months
• People aged 18 to 85 years old (or over 18 if local laws require)
• People whose AF symptoms have continued despite trying at least one anti-arrhythmia medication (a heart rhythm drug from a specific class), or who had to stop taking such medication due to intolerable side effects
• People who are willing and able to give their informed consent to participate
• People who have had a standard heart health check-up and have been assessed as a suitable candidate for an investigational procedure by the study doctors

Who may not be able to join:

• People whose left atrium (a chamber of the heart) is enlarged beyond a certain size (5.5 cm or more)
• People who have had any heart surgery, a heart attack, a coronary artery procedure or stent, unstable chest pain, or inflammation around the heart within the past 3 months
• People who have had a stroke, mini-stroke (TIA), or a blood clot event within the past 6 months
• People who have previously had a procedure involving the left atrium, such as a prior ablation, a closure procedure for a hole in the heart, or a procedure to close off the left atrial appendage
• People who have a planned heart procedure (such as valve replacement, heart implant, or certain closure or recording device procedures) scheduled during or after the trial follow-up period
• People who have not been taking blood-thinning medication (oral anticoagulation) for at least 3 weeks before the procedure
• People found to have a blood clot in the left atrium on imaging within 48 hours before the procedure
• People who already have a permanent pacemaker, a specialised pacemaker for heart failure, or any implantable heart defibrillator device
• People who have previously been diagnosed with narrowing of the pulmonary veins (the blood vessels connected to the heart)
• People who have had heart valve surgery or a valve procedure, or who have an artificial heart valve
• People with moderate to severe narrowing of the mitral valve, or more than moderate leaking of the mitral valve
• People with moderate to severe heart failure (classified as NYHA Class III or IV) or with significantly reduced heart pumping function (ejection fraction of 35% or less)
• People with a history of high blood pressure in the lungs (pulmonary hypertension above a certain level), severe lung disease, or restrictive lung disease
• People with rheumatic heart disease
• People who cannot safely take blood-thinning medications (such as heparin, warfarin, apixaban, or dabigatran)
• People with an active infection anywhere in the body
• People with certain structural heart muscle conditions, such as hypertrophic cardiomyopathy or infiltrative cardiomyopathy
• People with a benign tumour in the heart called an atrial myxoma
• People whose AF is caused by a known, treatable condition — such as an overactive thyroid that is not yet controlled, severe untreated sleep apnea, or recent alcohol poisoning
• People with a history of abnormal bleeding or a clotting disorder
• People with significantly reduced kidney function (eGFR below 30), or a history of kidney dialysis or kidney transplant
• People with a history of severe ongoing digestive problems affecting the oesophagus or stomach, or untreated acid reflux
• People who have had an organ or bone marrow transplant, or who are currently being assessed for a transplant
• People who are pregnant, breastfeeding, or of childbearing potential and not using a reliable form of contraception or abstinence
• People the study investigators determine are otherwise unsuitable to participate — for example, due to uncontrolled substance addiction, a congenital condition, or physical fragility
• People with a Body Mass Index (BMI) above 40
• People with other significant uncontrolled or unstable medical conditions, such as certain abnormal heart rhythms, an overactive thyroid, or a significant clotting disorder
• People with a life expectancy of less than one year
• People currently participating, or planning to participate, in another clinical study of a drug, device, or biological treatment during this trial — unless pre-approved by the trial sponsor
• People who are unwilling or unable to follow the study procedures and attend required follow-up visits

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