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:

• Adults aged 18 or older who are male or not currently pregnant
• People who have been diagnosed with a type of irregular heartbeat called atrial fibrillation (AF) that is not caused by a damaged heart valve
• People whose AF-related stroke risk score meets a certain threshold — at least 2 points for males or at least 3 points for females, based on a standard scoring tool called CHA2DS2-VASc (confirm with trial site)
• People whose treating doctor determines that a blood-thinning and anti-clotting medication plan, as outlined in the study, would be appropriate for them after the procedure
• People whom a screening committee and the study investigator have determined are suitable for the LAA ligation procedure used in this trial
• People who have been fully informed about the study, agree to its requirements including follow-up visits, and have signed a written consent form approved by an ethics committee

Who may not be able to join:

• People who are pregnant, breastfeeding, or planning to become pregnant within one year after the procedure; females of childbearing age must have a negative pregnancy test within 7 days before the procedure
• People whose AF has only occurred once or is considered reversible — for example, if it was caused by a thyroid problem, alcohol intoxication, injury, or a recent major surgery
• People who need long-term blood-thinning medication for a reason other than AF, such as a history of unprovoked blood clots or a mechanical heart valve
• People with very severe heart failure classified as New York Heart Association functional class IV (confirm with trial site)
• People who have had previous heart surgery or any surgery that required opening the breastbone (sternotomy)
• People who have had a stroke or mini-stroke (TIA) within the past 3 months
• People who have had a heart attack within the past 3 months
• People who have had a heart procedure within the past 30 days, or who have one planned within 60 days after the trial procedure
• People who have heart surgery or breastbone-opening surgery planned within 60 days after the trial procedure
• People who have had a non-heart-related procedure or surgery within the past 30 days, or who have one planned within 60 days after the trial procedure
• People with a history of symptomatic pericarditis (inflammation of the lining around the heart, either short-term or long-term)
• People who have evidence of a tumour in the heart
• People with significantly reduced kidney function (eGFR below 30) or who are currently on dialysis
• People with abnormal platelet counts or white blood cell counts, or a known tendency to bleed excessively
• People with an active blood infection (bacteremia)
• People with a known allergy or serious reaction to aspirin, heparin, or certain blood-thinning medications, or who have a contrast dye sensitivity that cannot be managed with medication before the procedure
• People currently taking part in another clinical trial of an investigational drug or device that could interfere with this study
• People who are unable to undergo general anaesthesia
• People whose heart cannot be adequately assessed using a specialised ultrasound (transesophageal echocardiogram/TEE) or CT scan
• People with another serious medical condition, a history of substance abuse, or a life expectancy of less than 5 years that may affect their ability to follow the study requirements or affect the reliability of the results

Based on heart imaging results, people may also not be able to join if:

• A blood clot is found inside the heart during screening
• The heart's pumping function is severely reduced (left ventricular ejection fraction below 30%)
• There is significant fluid around the heart or signs of pericarditis or cardiac tamponade
• Certain measurements of the heart's anatomy do not meet the requirements for the procedure (confirm with trial site)
• The anatomy of the heart, or any previous procedures, would prevent the specific surgical approach required by this trial
• The shape or structure of the area of the heart targeted by the procedure makes the intervention unsuitable, in the opinion of the screening committee

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