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:

• You are 75 years old or older
• You have been diagnosed with a type of irregular heartbeat called atrial fibrillation (AF) that is not caused by a heart valve problem
• Your doctor has calculated that you have a high risk of stroke based on a standard scoring system (a score of 3 or higher on a scale called CHA2DS2-VASc)
• Either you already had a catheter ablation procedure (a treatment for AF) between 90 and 180 days ago, OR you are scheduled to have one within 10 days of joining the trial
• Your doctor believes you can safely take the blood-thinning medicines required by this study
• You are able to have a specialised heart scan (either through your throat or using a CT scanner of your chest)
• You are willing and able to sign the consent form agreeing to take part
• You are willing to come back for all follow-up appointments and check-ups during the trial

Who may not be able to join:

• A scan has found a blood clot in a specific part of your heart (the left atrium or left atrial appendage)
• You had a serious bleeding episode in the 14 days before joining, or treatment for bleeding is still planned
• You need to take blood thinners long-term for a reason other than your AF, and you would not be able to stop taking them after a device is fitted
• You had a heart procedure or major surgery (other than your AF ablation or a heart rhythm reset) in the 30 days before joining, or one is planned within 60 days after joining
• Your life expectancy is less than 2 years, or you have an active cancer, a heart infection, an uncontrolled infection, or fluid pressing on your heart
• Your level of frailty falls at either the very fit/non-frail end (score 1–3) or the severely frail/terminally ill end (score 7–9) on a standard frailty scale (confirm with trial site)
• Your doctor considers blood-thinning medicines unsuitable for you due to bleeding risk, allergies, or other concerns
• You are currently taking part in another clinical trial that could affect this study
• You had a stroke or a mini-stroke (TIA) in the 60 days before joining
• You had a heart attack in the 90 days before joining
• You have had a previous repair of a hole in the heart (ASD), or you already have a device fitted to close a hole in the heart
• You have an artificial (mechanical) heart valve anywhere in your heart
• You are pregnant or planning to become pregnant during the study
• You have a physical reason that makes a catheter-based procedure through a blood vessel unsafe for you
• You have been diagnosed with the most severe level of heart failure (NYHA Class IV)
• You have previously had surgery to close off a small pouch in your heart called the left atrial appendage

Additional reasons you may not be able to join based on a heart ultrasound (echocardiogram):

• Your heart's pumping strength is very low (less than 30% on a measure called ejection fraction)
• You have fluid around your heart measuring more than 5mm all the way around
• You have a combination of a hole between the upper chambers of your heart and a bulging wall between those chambers measuring more than 15mm (confirm with trial site)
• You have a hole between the upper chambers of your heart with a large amount of blood flowing through it, detected by a bubble test (confirm with trial site)
• You have moderate or severe narrowing of your mitral heart valve

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