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 been diagnosed with symptomatic atrial fibrillation (an irregular heartbeat) that comes and goes or is persistent, with at least two recorded episodes in the past 12 months confirmed by heart tracing tests.
• People for whom at least one heart rhythm medication has not worked or has caused intolerable side effects.
• People whose doctor has assessed them as a suitable candidate for a catheter ablation procedure (a procedure to correct abnormal heart rhythms).
• People aged 18 or older but under 75 years of age.
• People who are willing and able to give their informed consent to participate.
• People who are willing, able, and have sufficient means to attend and complete all required appointments and tests before, during, and after the procedure.

Who may not be able to join:

• People whose atrial fibrillation has been continuous for more than 12 months.
• People whose atrial fibrillation is caused by an imbalance of body salts, a thyroid condition, recent heavy alcohol use, or another reversible or non-heart-related cause.
• People who have previously had a catheter-based or surgical procedure on the left side of the heart, including procedures to close a hole in the heart or seal off the left atrial appendage.
• People who have had heart valve surgery or a valve procedure, or who have an artificial heart valve.
• People who have previously had a stent placed in a neck artery or a surgical procedure to clear a neck artery.
• People who have had any heart procedure or coronary artery procedure within the 90 days before the start of the trial.
• People who have had a coronary artery bypass graft (heart bypass surgery) within the 6 months before the ablation procedure.
• People who are on a waiting list for a heart transplant or other heart surgery expected within 12 months after the ablation procedure.
• People who have an implanted heart defibrillator device (with or without a pacing function).
• People who have had a stroke or a mini-stroke (TIA) within the past 6 months.
• People who have a blood clot detected in the upper left chamber of the heart on a scan.
• People with a history of problems with blood clotting or abnormal bleeding.
• People for whom long-term blood thinning medication would not be medically appropriate.
• People who have had a heart attack within the 3 months before the start of the trial.
• People with a body mass index (a measure of weight relative to height) above 40.
• People whose left upper heart chamber is larger than a certain size as measured by imaging (confirm with trial site for specific measurements relevant to each type of atrial fibrillation).
• People who have been diagnosed with a benign heart tumour called an atrial myxoma.
• People whose heart pumping strength (left ventricular ejection fraction) is below 40%.
• People with uncontrolled heart failure or heart failure that significantly limits physical activity (classified as NYHA Class III or IV).
• People with rheumatic heart disease.
• People with a condition called hypertrophic cardiomyopathy (abnormal thickening of the heart muscle).
• People experiencing unstable angina (unpredictable chest pain at rest or with minimal activity).
• People with moderate to severe narrowing of the mitral heart valve.
• People with severe leaking of the mitral heart valve, as measured by specific clinical thresholds (confirm with trial site).
• People with primary pulmonary hypertension (high blood pressure in the lung arteries not caused by another condition).
• People with significant lung disease or a long-term breathing condition.
• People with kidney failure who require dialysis.
• People who are currently acutely unwell, have an active infection throughout the body, or have sepsis.
• People with a significant birth defect or medical condition that, in the opinion of the trial investigator, would prevent safe participation or reliable follow-up.
• People who are known to be pregnant, are breastfeeding, or are capable of becoming pregnant and are not using a reliable form of contraception or practising abstinence.
• People who are currently participating, or plan to participate, in another clinical trial of a drug, device, or biological treatment during the study period, unless the trial sponsor has given prior approval.
• People who have a blood clot, tumour, or other abnormality in the blood vessels that would prevent safe insertion or movement of the catheter.
• People with a known dependency on drugs or alcohol.
• People whose life expectancy is less than 12 months.
• People who are considered a vulnerable subject as defined by the trial (confirm with trial site).

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