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 the legal age of consent in their region)
• People with a stroke risk score (called CHA2DS2-VASc) of 2 or more for men, or 3 or more for women
• People whose doctor expects them to be able to stop blood-thinning medication within 90 days after the main procedure
• People who are able to follow the required medication plan after the procedure, which involves at least 60 days of blood-thinning medication followed by a single antiplatelet medication
• People who are already planning to have a catheter ablation procedure (a heart rhythm treatment involving the pulmonary veins) for symptomatic, recurring atrial fibrillation (AF) that has not responded to medication
• People with a confirmed diagnosis of paroxysmal AF (episodes that start and stop on their own) supported by a doctor's note recording at least 2 episodes in the past 12 months, plus at least one episode confirmed by a heart tracing (ECG) in the past 12 months
• People with a confirmed diagnosis of persistent AF (continuous AF lasting more than 7 days but less than 1 year), supported by a doctor's note and either a 24-hour heart monitor recording or two separate heart tracings taken at least 7 days apart, with the most recent taken within 180 days of enrolling (confirm with trial site for full documentation requirements)

Who may not be able to join:

• People with a known allergy or medical reason preventing them from taking blood-thinning medications (NOACs) or aspirin after the procedure
• People who need to take a specific type of blood-thinning tablet called a P2Y12 inhibitor after the procedure (for example, following a coronary stent placement)
• People who have an artificial (prosthetic) heart valve
• People who have a filter implanted in the large vein that runs through the abdomen (inferior vena cava filter)
• People whose heart's pumping strength (left ventricular ejection fraction) is 30% or below
• People with the most severe category of heart failure (Class IV on the NYHA scale), meaning symptoms occur even at rest
• People who have had any invasive procedure or surgery (other than a diagnostic heart catheter) within the 30 days before the main study procedure
• People who have had a stroke or mini-stroke (transient ischemic attack) within the 90 days before the study procedure
• People who have previously had a surgical or device-based procedure on the left atrial appendage (a small pouch in the heart)
• People previously diagnosed with long-standing persistent AF, meaning continuous AF lasting more than 1 year
• People whose irregular heart rhythm is caused by a reversible condition, such as a thyroid disorder, acute alcohol intoxication, electrolyte imbalance, severe untreated sleep apnea, or a major surgical procedure within 90 days before the study procedure
• People who are unable to receive heparin or a suitable alternative blood-thinning medication during the procedure
• People who have a stent, narrowing, or blockage in one of their pulmonary veins (the veins connecting the lungs to the heart)
• People with severe leakage of the mitral heart valve, meeting specific measurement thresholds (confirm with trial site)
• People with severe kidney failure (a filtration rate below 30 ml/min/1.73m²) or who are on regular dialysis
• People with severe lung disease, such as severe chronic obstructive pulmonary disease or other serious lung conditions causing persistent symptoms
• People with a condition called hypertrophic cardiomyopathy, where the heart muscle wall is abnormally thick (15 mm or more) without another explanation such as high blood pressure or aortic valve narrowing

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