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 aged 18 or older (or older if local laws require it)
• People who have had exactly one previous catheter-based heart procedure (done from inside the heart) to treat atrial fibrillation (AF), which at minimum targeted the pulmonary veins (the vessels connecting the lungs to the heart)
• People who have a doctor's documented diagnosis of persistent AF (a type of irregular heartbeat that lasts continuously), either before or after their previous procedure
• People who have documented evidence that their AF symptoms returned at least 60 days after their previous procedure, recorded by an approved heart-monitoring device
• People who had persistent AF before their previous procedure and have documented return of symptomatic AF or a related irregular heart rhythm at least 60 days after that procedure, recorded by an approved heart-monitoring device
• People who are willing and able to give informed consent to participate
• People who are willing and able to attend all required follow-up visits and tests at an approved study centre

Who may not be able to join:

• People whose left atrium (one of the heart's chambers) is enlarged beyond a certain size, as shown by imaging
• People with a current non-cancerous heart tumour called an atrial myxoma
• People with abnormalities, narrowing, or stents in their pulmonary veins (certain types may still be permitted — confirm with trial site)
• People with a current blood clot in the left atrium
• People with a history of sustained dangerous heart rhythm problems (sustained ventricular tachycardia or ventricular fibrillation)
• People whose AF is caused by a treatable or non-heart-related condition, such as a thyroid problem, electrolyte imbalance, or alcohol use
• People who currently have or are expected to receive certain implanted heart devices, such as a defibrillator or cardiac resynchronisation therapy device, or an implantable loop recorder other than the specific LUX-Dx device used in this study
• People who are entirely dependent on a pacemaker to maintain their heartbeat
• People who have had certain previous heart procedures, including an atrial septal patch, baffle, or closure device (certain exceptions may apply — confirm with trial site)
• People who have a left atrial appendage closure device, unless it is a WATCHMAN device implanted more than 90 days before enrolment
• People with any artificial heart valve, valve repair ring, moderate-to-severe mitral valve narrowing, significant mitral valve leakage, or moderate-to-severe aortic valve narrowing
• People with a condition called hypertrophic cardiomyopathy (a thickening of the heart muscle)
• People with a filter in the major vein of the abdomen (IVC), an inability to access the groin veins, or other reasons why groin access is not possible
• People who are waiting for a heart transplant or other heart surgery within the next 12 months
• People with severe dysfunction of the right side of the heart, confirmed by imaging or other testing
• People with severe heart failure (classified as NYHA Class III or IV — meaning significant or severe limitations on physical activity)
• People whose heart pumping function (ejection fraction) has been measured at below 40% in the past 12 months
• People with uncontrolled high blood pressure (above specific levels on two separate measurements, unless the doctor believes this is due to anxiety in a clinical setting)
• People with a Body Mass Index (BMI) above 45
• People with a CHA2DS2-VASc score of 5 or higher (a medical score used to assess stroke risk in people with AF — confirm with trial site)
• People who, within the 90 days before joining the study, have had a heart attack, unstable chest pain, a heart procedure or surgery, a heart failure hospital admission, inflammation around the heart, gastrointestinal (gut) bleeding, a stroke or mini-stroke or brain bleed, a blood clot or clotting event, a carotid artery procedure, or poorly controlled diabetes
• People with significant congenital (present from birth) heart disease that has left lasting structural or electrical problems in the heart
• People with a known inherited condition called congenital methemoglobinemia (a blood disorder)
• People with a known inherited enzyme deficiency called G6PD deficiency
• People who have had a solid organ or blood-related transplant, or who are currently being assessed for one
• People with a history of, or current evidence of, partial paralysis or weakness of the diaphragm (the muscle used for breathing)
• People with severe lung disease, severe high blood pressure in the lungs, or any lung condition affecting blood oxygen levels or requiring supplemental oxygen
• People with significantly reduced kidney function (eGFR below 30), or any history of kidney dialysis or kidney transplant
• People with an active cancer, other than a specific type of skin cancer (squamous cell carcinoma)
• People with significant digestive or oesophageal (food pipe) problems, such as severe reflux, stomach-emptying problems, fungal infection of the oesophagus, or active stomach ulcers
• People with an active widespread infection in the body
• People who require use of a specific class of medications called phosphodiesterase inhibitors within 24 hours of the ablation procedure
• People with a known allergic reaction to nitroglycerin (a heart medication), not including low blood pressure as a side effect
• People with a known blood clotting disorder or bleeding condition (such as haemophilia or von Willebrand disease)
• People who cannot or are unwilling to take blood-thinning medication before, during, and after the procedure
• Women who are pregnant, breastfeeding, not using medical contraception, or planning to become pregnant during the study period
• People whose general health, in the treating doctor's opinion, would make participation unsafe, interfere with the study, or affect the reliability of the results
• People who are unwilling or unable to have a small monitoring device (the LUX-Dx ICM) inserted under the skin on a long-term basis
• People currently enrolled in another research study or registry that would interfere with this trial (participation in certain government-required or purely observational registries may be permitted — confirm with trial site)
• People with a life expectancy of less than one year

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