Phase 4 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 have been diagnosed with atrial fibrillation (an irregular heartbeat) that is not caused by a faulty or mechanical heart valve
• People whose stroke risk score (called CHA2DS2-VA) is 2 or higher, indicating a moderate to high risk of stroke
• People who meet the medical guidelines for having a left atrial appendage closure (LAAC) procedure, including those at higher risk of bleeding
• People who have already had a successful LAAC procedure, meaning the device was placed without significant leakage or serious complications
• People whose heart anatomy is compatible with a specific closure device called the Boston Scientific WATCHMAN FLX Pro
• People who are able to take the specific blood-thinning or antiplatelet medications required by this study
• People who are willing and able to attend all required follow-up visits after the LAAC procedure
• People who have been fully informed about the study and have signed a written consent form to participate

Who may not be able to join:

• People who are currently enrolled in another clinical trial (participation in government-required or observation-only registries without any associated treatment may be acceptable — confirm with trial site)
• People who need long-term blood thinners for reasons unrelated to atrial fibrillation, such as a history of blood clots in the lungs or legs, or a clotting disorder
• People who need ongoing antiplatelet medicines (such as aspirin or similar drugs) for reasons other than the LAAC procedure, for example due to a past heart attack, stroke, mini-stroke, significant narrowing of the arteries, or a blood disorder
• People who cannot take blood-thinning medications (DOACs or warfarin-type medicines), cannot take aspirin, or have a known allergy to aspirin
• People who have had, or are planned to have, a heart or non-heart procedure or surgery within 45 to 60 days before or after the LAAC procedure (for example, a heart rhythm procedure, heart stenting, cataract surgery, or similar)
• People who have had a stroke or mini-stroke (TIA) within the 30 days before enrolling in the trial
• People who are currently experiencing active bleeding
• People who do not have a left atrial appendage, or whose left atrial appendage has already been surgically closed
• People who have had a heart attack in the 30 days before enrolling in the trial
• People who have previously had a repair to the wall between the heart's upper chambers, or who have a device already in place to close a hole in that wall
• People who have a mechanical heart valve anywhere in the heart
• People who cannot undergo a trans-oesophageal echocardiogram (a type of heart imaging done via the throat) due to a known medical reason
• People who have an active infection at the time of the trial
• People who have severe heart failure classified as the most serious level (NYHA Class IV) at the time of enrolment
• People who are pregnant, breastfeeding, or planning to become pregnant
• People whose life expectancy is less than 2 years
• People who need emergency surgery for any reason
• People who, in the treating doctor's judgement, have medical, personal, or psychological circumstances that would prevent them from safely following the study requirements
• People whom the trial doctor considers unsuitable for participation for any other reason

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