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 are 18 years of age or older (or older if required by local laws)
• People who have been diagnosed with a type of irregular heartbeat called atrial fibrillation (AF) that comes and goes, or that has lasted a long time, and is not caused by something temporary or reversible
• People who experience symptoms related to their atrial fibrillation, and/or have heart failure or reduced heart pumping function
• People whose stroke risk score (called CHADSVASc) is 2 or higher for men, or 3 or higher for women
• People for whom the treating doctor has identified a medical reason to consider a non-drug option for reducing stroke risk, rather than long-term blood thinning medication
• People who are willing and able to give their informed consent to participate
• People who are willing and able to attend all required visits and tests at an approved trial centre

Who may not be able to join:

• People who have previously had a procedure to treat atrial fibrillation using ablation, including surgical ablation
• People who have previously had a procedure to close off the left atrial appendage (a small pouch in the heart)
• People who have a mass or blood clot inside their heart
• People who have a bleeding disorder or who cannot tolerate taking blood thinning medication for a short period of time
• People whose life expectancy is less than one year
• People who have had a heart attack, stroke, or heart surgery within the past 90 days
• People who are unable to attend follow-up appointments after the procedure, or whose cognitive (thinking and understanding) difficulties would prevent them from understanding the risks and benefits of the procedure
• People who have an active infection anywhere in their body
• People who have a mechanical heart valve in the path the procedure catheter would need to pass through, or who have severe narrowing of the mitral heart valve
• People who have a filter device placed in a major vein (vena cava), or a known blood clot in the groin vein, where the catheter would need to be inserted from the groin
• People who have a congenital heart condition (a heart problem present from birth) where the abnormality increases the risk of the ablation procedure — for example, significant unusual positioning of the heart or major blood vessels
• People who are women of childbearing age and are currently pregnant, breastfeeding, not using a reliable form of contraception, or planning to become pregnant during the study period
• People whose atrial fibrillation has been continuous for more than 10 years
• People whose left atrial appendage shape or structure is not suitable for the closure device used in this trial (confirm with trial site)
• People whose left atrium (a chamber of the heart) measures more than 6 cm in diameter

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