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 years or older.
• People who have been diagnosed with a type of irregular heartbeat called atrial fibrillation (AF) that is not caused by a problem with the heart's mitral valve or a mechanical heart valve.
• People whose stroke risk score (called CHA₂DS₂-VASc) is 2 or higher for men, or 3 or higher for women (a doctor calculates this score based on health history).
• People who have a medical reason why they cannot take blood-thinning medication long-term.
• People who have already had a specific heart device called a LAmbre Left Atrial Appendage Closure (LAAC) device successfully implanted, with no complications during the hospital stay after the procedure.
• People who are able and willing to attend all required follow-up visits and check-ups.
• People who have signed a form giving their informed consent to take part.

Who may not be able to join:

• People who are currently enrolled in another research study that involves a treatment or intervention (participation in an observation-only registry with no treatments may be acceptable — confirm with trial site).
• People who need to take blood-thinning medication long-term for a reason other than reducing stroke risk from AF, such as a condition that makes their blood clot too easily.
• People who are allergic to, or medically unable to take, both aspirin and clopidogrel (two common blood-thinning medications).
• People who need to take aspirin or clopidogrel long-term for another ongoing medical condition, such as chronic heart disease or peripheral artery disease.
• People who have had, or are planning to have, any heart or non-heart procedure or surgery within 30 days before or 60 days after the device implant (this includes procedures such as cardioversion, coronary artery procedures, heart ablation, or cataract surgery).
• People who have had a stroke (of any type) or a mini-stroke (also called a transient ischemic attack, or TIA) within the 30 days before enrolling in the trial.
• People who have had a major bleeding event within the 30 days before enrolling, or whose bleeding has not fully resolved, or who have a planned procedure to address a bleeding source.
• People who currently have active bleeding.
• People who have had a heart attack documented in their medical records within the 30 days before enrolling.
• People who have had a previous repair to the wall between the heart's upper chambers, or who already have a device implanted to close a hole in that wall (ASD or PFO device).
• People who are capable of becoming pregnant, or who plan to become pregnant during the study (the study doctor will assess this).
• People who have a documented life expectancy of less than one year.

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