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 persistent atrial fibrillation (an irregular heart rhythm lasting more than 7 days but no longer than 365 days) that causes symptoms and has not responded to medication, confirmed by medical records
• People whose AF has been confirmed by either a 24-hour heart rhythm recording, or two separate heart rhythm recordings taken at least 7 days apart, both done within the past 180 days
• People who are willing and able to give informed consent to participate
• People who are willing and able to attend all follow-up visits and tests at an approved trial centre
• People who are willing to have a small heart monitoring device (called the LUX-Dx™ insertable cardiac monitor) placed under the skin during the study, or who already have one inserted within the past 6 months and are willing to follow the device's transmission instructions

Who may not be able to join:

• People whose left chamber of the heart (left atrium) is enlarged beyond a certain size, based on imaging or doctor records
• People who have previously had a catheter ablation procedure on the left atrium
• People who have previously had surgery on any part of the heart's upper chambers
• People who currently have a tumour in the heart (atrial myxoma) or a blood clot in the left atrium
• People who have an abnormality, narrowing, or stent in the pulmonary veins (the blood vessels connecting the lungs to the heart), with some exceptions (confirm with trial site)
• People with a history of a sustained dangerous fast heart rhythm originating in the lower chambers of the heart (ventricular tachycardia or ventricular fibrillation)
• People with severe dysfunction of the right side of the heart, as shown by imaging or other heart tests
• People whose irregular heart rhythm 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 resynchronisation device
• People who have any other implantable heart monitor other than the LUX-Dx™ device
• People who have certain devices or patches already implanted in the heart, such as those used to close a hole between the heart's upper chambers
• People who have a device already in place to close off the left atrial appendage (a small pouch in the heart)
• People who have an artificial heart valve, a narrowed heart valve, or a ring or repair on a heart valve
• People with moderate to severe narrowing of the mitral valve, or more than moderate leaking of the mitral valve
• People with hypertrophic cardiomyopathy (a thickened heart muscle) or amyloid cardiomyopathy (a condition where abnormal protein builds up in the heart)
• People who have a filter in the large vein leading to the heart (IVC filter), cannot have a vein accessed in the groin area, or have another reason this type of access is not possible
• People who are waiting for a heart transplant or have other heart surgery planned within the next 12 months
• People with advanced heart failure (classified as NYHA Class III or IV, meaning significant or severe limitations on physical activity) (confirm with trial site)
• People whose most recent heart pumping function test (LVEF) in the past 12 months showed the heart pumping at less than 40% of normal capacity
• People with a Body Mass Index (BMI) above 45
• People with a known blood clotting disorder or bleeding condition
• People who are unable or unwilling to take blood-thinning medication before, during, and after the procedure
• Women who are confirmed to be pregnant or breastfeeding at the time of the procedure
• People with severe lung disease, severe high blood pressure in the lungs, or any lung condition that affects oxygen levels in the blood or requires supplemental oxygen
• People with an active cancer diagnosis, other than a specific type of skin cancer (squamous cell carcinoma)
• People with significant digestive problems involving the oesophagus or stomach, such as severe acid reflux, inflammation of the oesophagus, a fungal infection of the oesophagus, stomach-emptying problems, or active stomach ulcers
• People with a known active infection anywhere in the body
• People with untreated severe obstructive sleep apnea (where breathing stops more than 30 times per hour during sleep)
• People whose doctor estimates their life expectancy to be less than one year
• People currently enrolled in another research study or registry that would interfere with this trial, unless it is a government-required registry or a purely observational registry with no treatments involved (each case must be reviewed by the trial sponsor)
• People who require a specific type of medication called phosphodiesterase inhibitors within 24 hours of the procedure
• People with uncontrolled high blood pressure (above certain levels on two separate measurements at the baseline assessment), unless the doctor determines this is due to anxiety in a clinical setting
• People with a CHA₂DS₂-VASc score of 5 or higher — a scoring system doctors use to assess stroke risk in people with atrial fibrillation (confirm with trial site)
• People with a known allergic reaction to a medication called nitroglycerin (not including low blood pressure as a side effect)
• People who are unwilling or unable to tolerate a small monitoring device inserted under the skin long-term
• People with certain congenital (present from birth) heart conditions that have left significant ongoing structural or electrical problems in the heart
• People with a known inherited condition called congenital methemoglobinemia
• People with a known enzyme deficiency called G6PD deficiency
• People who have had a solid organ or bone marrow transplant, or who are currently being assessed for one
• People with any history or current signs of paralysis or weakness of one side of the diaphragm (the muscle used for breathing)
• People with a documented history of a specific type of chest pain caused by coronary artery spasm (Prinzmetal Angina), or severe coronary artery disease that cannot be treated with procedures to restore blood flow
• People with significantly reduced kidney function (eGFR below 30), or any history of kidney dialysis or kidney transplant
• People with any other health condition that, in the investigator's opinion, would make participation unsafe, interfere with the study, or affect the reliability of results
• People who, within the 90 days before consenting to join the trial, have experienced any of the following: a heart attack, unstable chest pain, or a procedure to open blocked coronary arteries; any heart surgery; a hospitalisation for heart failure; inflammation around the heart or a fluid build-up around the heart causing symptoms; bleeding in the digestive system; a stroke, mini-stroke (TIA), or bleeding in the brain; a blood clot or clot-related event outside the brain; a procedure to treat narrowing of the carotid arteries in the neck; or uncontrolled diabetes or a blood sugar control measurement (HbA1c) above 8.0%

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