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 a type of irregular heartbeat called atrial fibrillation (AF) that is not the short, intermittent kind (known as "non-paroxysmal" AF)
• People who have already tried at least one medication to control their heart rhythm, but it either did not work or caused side effects they could not tolerate
• People between the ages of 18 and 85 at the time of signing the consent form
• People who are already scheduled to have an AF ablation procedure (a procedure to treat irregular heartbeat) as part of their normal medical care
• People who are able and willing to attend all required study visits and follow study procedures
• People who have signed the study's informed consent form
• People who, during their ablation procedure, are found to have areas of low electrical activity (called "low voltage") in the left chamber of the heart, as detected by a special 3D mapping system

Who may not be able to join:

• People who have previously had a catheter-based or surgical ablation procedure on the left side of the heart for AF or a certain type of irregular heartbeat called atypical atrial flutter (including procedures known as MAZE or mini-MAZE) — note: prior ablation for some other heart rhythm conditions may still be acceptable (confirm with trial site)
• People with severe or poorly controlled heart failure
• People whose heart is pumping at less than 20% of its normal capacity (very low heart function)
• People who have had a serious abnormal heart rhythm called ventricular tachycardia that required treatment in the past 6 months
• People whose left heart chamber (left atrium) measures more than 60 mm on an ultrasound of the heart
• People who have been in continuous atrial fibrillation for 1 year or longer at the time of joining the study
• People with severe high blood pressure in the lungs (a condition called severe pulmonary hypertension)
• People with unstable heart valve disease
• People whose AF is caused by something treatable, such as a thyroid problem, electrolyte imbalance, or another reversible non-heart-related cause
• People who are considered a poor candidate for general anaesthesia
• People whose life expectancy is estimated to be less than 1 year
• People who have had a heart attack or open-heart bypass surgery within the past 3 months
• People found to have a blood clot in the left atrium on imaging done within 4 weeks before the ablation procedure
• People who have had a blood clot-related event (such as a stroke or clot) within the past 6 months
• People who cannot safely take blood-thinning medication
• People who are unable to use a small implanted heart monitor or wear an external heart monitor (Holter monitor) continuously for 4 weeks, to track AF episodes
• People with a significant birth defect or medical condition that may affect the reliability of study results
• People who are pregnant — a pregnancy test is required for those who have not yet reached menopause or who have not had a sterilisation procedure
• People currently enrolled in another research study involving a drug or medical device
• People in whom a complete electrical map of the heart cannot be performed during the procedure
• People with a medical or psychological condition, or a history of not following medical instructions, that may affect study outcomes

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