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 whose doctor has determined they need both the FARAPULSE™ heart rhythm treatment system and the WATCHMAN device to close off a part of the heart called the left atrial appendage, based on standard medical care.
• People who are willing and able to give their informed consent to participate.
• People who are willing and able to attend all required study visits and tests at an approved study centre.
• People who are 18 years of age or older, or who have reached the legal age to give consent under the laws that apply to them.

Who may not be able to join:

• People who have previously had a procedure to treat an irregular heartbeat (atrial fibrillation ablation).
• People whose atrial fibrillation is caused by something that can be reversed, such as an imbalance of body minerals, thyroid disease, alcohol use, or other non-heart-related causes.
• People whose left atrial appendage has already been surgically closed or blocked off.
• People whose left atrial appendage shape or size is not suited to receiving a closure device.
• People with a known or suspected non-cancerous tumour in the heart called an atrial myxoma.
• People who have a blood clot inside the heart.
• People who have a patch or baffle between the upper chambers of the heart, have had a previous repair of the wall between those chambers, or already have a device in place for a hole in the heart (ASD or PFO device).
• People who have an artificial mechanical heart valve in any position in the heart.
• People who have had a heart attack within the 30 days before joining the study.
• People who have had a stroke (of any type) or a mini-stroke (TIA) within the 90 days before joining the study.
• People who are planned to have an electrical procedure to reset the heart's rhythm within 30 days after having the closure device implanted.
• People whose doctors have determined that accessing their blood vessels for the procedure would not be possible.
• People for whom a catheter-based procedure would not be appropriate due to body size, certain heart or blood vessel abnormalities, or active conditions such as infection, a bleeding disorder, or unstable chest pain.
• People who have any active health conditions such as infection, a bleeding disorder, or unstable chest pain.
• People who are unable to take blood-thinning medication or aspirin in the short term for reasons unrelated to atrial fibrillation.
• People who are pregnant or planning to become pregnant.
• People whose doctor estimates they have a life expectancy of one year or less.
• People who are currently taking part in another research study or registry that would conflict with this trial — though participation in certain government-required registries or observation-only registries with no treatments attached may be reviewed individually by the study sponsor to assess suitability (confirm with trial site).

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