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 at least 18 years old (or older if local laws require it)
• People who have atrial fibrillation (an irregular heart rhythm) that causes symptoms, has been confirmed by medical testing, and has not been controlled by medication — either the type that comes and goes (paroxysmal) or the type that stays for longer periods (persistent)
• People who are willing and able to give written consent to participate
• People who are willing and able to attend all required follow-up visits and study appointments at an approved study location

Who may not be able to join:

• People whose left atrial chamber (a part of the heart) is enlarged beyond a certain size, measured by specific heart imaging methods
• People who have previously had any ablation procedure (using heat, cold, or other energy) on the heart's upper chambers to treat an irregular rhythm, with the exception of certain specific right-sided procedures
• People who have previously had surgery on the upper chambers of the heart
• People who currently have a non-cancerous tumour called a myxoma in the upper left chamber of the heart
• People who have abnormalities, narrowing, or prior stenting in the pulmonary veins (the blood vessels connecting the lungs to the heart), with some exceptions (confirm with trial site)
• People who currently have a blood clot in the upper left chamber of the heart
• People with a history of serious, sustained irregular rhythms originating in the lower chambers of the heart (ventricular tachycardia or ventricular fibrillation)
• People whose atrial fibrillation 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 need, a pacemaker, defibrillator, or cardiac resynchronization device
• People who have an implanted heart monitor other than a specific device called the LUX-Dx
• People who have a device or patch previously placed to close a hole between the upper chambers of the heart
• People who have a device already in place to close off a part of the heart called the left atrial appendage
• People with significant heart valve problems, including artificial valves, valve rings or repair clips, moderate to severe narrowing of the mitral or aortic valve, or severe leakage of the mitral or tricuspid valve
• People with certain types of thickened or protein-affected heart muscle conditions (hypertrophic or amyloid cardiomyopathy)
• People who have a filter in a large vein in the abdomen, cannot have vascular access established, or have a medical reason preventing access through the groin area
• People who are waiting for a heart transplant or other heart surgery planned within 12 months (note: a left atrial appendage closure procedure may be allowed if performed at least 60 days after the study procedure — confirm with trial site)
• People with severely reduced function of the right side of the heart, as assessed by the treating doctor
• People with congenital (present from birth) heart disease that has left significant ongoing structural or electrical abnormalities, or inherited electrical heart rhythm conditions
• People with a known inherited condition called congenital methemoglobinemia
• People with a known enzyme deficiency called G6PD deficiency
• People who have had, or are being evaluated for, a solid organ or blood-related transplant
• People with a current or past history of partial or full paralysis of one side of the diaphragm (the muscle used for breathing)
• People with a specific type of chest pain caused by coronary artery spasm (Prinzmetal angina) or severe coronary artery disease that cannot be treated with a procedure to restore blood flow
• People with a known condition affecting blood clotting or causing unusual bleeding
• People with reduced kidney function, a history of dialysis, or a kidney transplant
• People with a known allergic reaction to a medication called nitroglycerin (other than low blood pressure as a side effect)
• People who need to take a specific class of medications called phosphodiesterase inhibitors within 24 hours before the ablation procedure
• People who have an active spinal cord stimulator implanted
• People with moderate to severe heart failure symptoms (classified as NYHA Class III or IV)
• People whose heart pumping function (left ventricular ejection fraction) has been measured at below 40% within the past 12 months
• People with a stroke risk score (CHA2DS2-VASc) of 5 or higher
• People with a body mass index (BMI) above 45.0
• People who are unable or unwilling to take blood-thinning medication around the time of the procedure
• People who are pregnant or breastfeeding at the time of the procedure
• People with severe lung disease, high blood pressure in the lung's blood vessels, or a need for supplemental oxygen due to a lung condition
• People with an active cancer diagnosis, with the exception of a specific type of skin cancer called squamous cell carcinoma
• People with significant digestive tract conditions such as severe inflammation of the oesophagus, uncontrolled acid reflux, stomach-emptying problems, a fungal infection of the oesophagus, or active stomach or intestinal ulcers
• People with a known active infection anywhere in the body
• People whose life expectancy is less than one year
• People already enrolled in another research study or registry that could interfere with this trial, with some exceptions for certain government-required or observation-only registries (confirm with trial site)
• People who have had a heart attack, unstable chest pain, or a procedure to open blocked heart arteries within the past 90 days
• People who have had inflammation around the heart or a symptomatic fluid build-up around the heart within the past 90 days
• People who have had gastrointestinal bleeding within the past 90 days
• People who have had heart surgery within the past 90 days
• People who have had a stroke, a temporary stroke-like event (TIA), or bleeding in the brain within the past 90 days
• People who have had a blood clot or clot-related event (not involving the brain) within the past 90 days
• People who have had a procedure on the carotid arteries in the neck within the past 90 days
• People who have been hospitalised for heart failure within the past 90 days
• People with uncontrolled diabetes or a blood sugar control measurement (HbA1c) above 8.0% within the past 90 days
• People who are unwilling or unable to have a small monitoring device (from the LUX-Dx family) implanted under the skin on a long-term basis
• People with any other medical condition that, in the treating doctor's opinion, would make participation unsafe, increase risk, or affect the reliability of the study results

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