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:

• Adults aged 18 or older (or older if required by local laws in the country where the trial is taking place)
• People who have been diagnosed with symptomatic atrial fibrillation (an irregular heart rhythm) that is either persistent (ongoing) or paroxysmal (comes and goes), confirmed by medical records
• People who are willing and able to give their informed agreement to take part
• People who are willing and able to attend all required follow-up visits and tests at an approved trial centre

Who may not be able to join:

• People whose left atrial chamber of the heart is enlarged beyond a certain size (as measured by medical imaging)
• People who have previously had any procedure to treat abnormal heart rhythms in the upper chambers of the heart (except for a specific type of procedure on the right side of the heart called right-sided SVT ablation)
• People who currently have a benign tumour in the heart's upper chamber (atrial myxoma)
• People who have abnormalities, narrowing, or stents 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 left upper chamber of the heart
• People with a history of sustained dangerous heart rhythm problems in the lower chambers of the heart (ventricular tachycardia or ventricular fibrillation)
• People whose atrial fibrillation is caused by a correctable or non-heart-related cause, such as an electrolyte imbalance, thyroid disease, or alcohol use
• People who currently have, or are expected to need, a pacemaker, defibrillator, or certain other heart devices or implants
• People with significant valve disease that causes symptoms or heart failure
• People with a condition called hypertrophic cardiomyopathy (a thickened heart muscle)
• People who have an artificial heart valve, ring, repair, or have had a certain valve procedure (balloon aortic valvuloplasty)
• People for whom doctors would be unable to access the necessary blood vessels in the groin for the procedure
• People with rheumatic heart disease
• People who are waiting for a heart transplant or other heart surgery within the next 12 months
• People with a known allergic reaction to the drug nitroglycerin
• People with severe coronary artery disease that cannot be treated with procedures to restore blood flow
• People who already have stents in certain heart arteries (the right coronary artery and the left circumflex artery)
• People with the most severe level of heart failure symptoms (classified as NYHA Class IV)
• People whose heart pumping function is significantly reduced (ejection fraction below 40%)
• People with poorly controlled high blood pressure (measured as above 160/95 mmHg on two separate readings at the baseline assessment)
• People with severe weakness of the right side of the heart, confirmed by medical testing
• People who have had any of the following within the 90 days before agreeing to join the trial: a heart attack, unstable chest pain, a procedure to open blocked heart arteries, any heart surgery, a hospital admission for heart failure, inflammation around the heart, a significant fluid collection around the heart, bleeding in the gut, a stroke, a mini-stroke (TIA), bleeding in the brain, a blood clot in another part of the body, or a procedure on the neck arteries
• People with a known blood clotting disorder (such as von Willebrand's disease or haemophilia)
• People who are unable or unwilling to take blood-thinning medication before, during, and after the procedure
• Women who are pregnant, breastfeeding, planning to become pregnant during the study period, or who are of childbearing age and not using medical contraception
• People with a body mass index (BMI) over 42
• People who have had a solid organ or blood-related transplant, or who are currently being assessed for one
• People with a known history of, or current evidence of, paralysis or weakness of one side of the diaphragm (the breathing muscle)
• People with severe lung disease, severe high blood pressure in the lung blood vessels, or any lung condition affecting oxygen levels or requiring supplemental oxygen
• People with significantly reduced kidney function (eGFR below 30), or a history of kidney dialysis or kidney transplant
• People with an active cancer diagnosis at the time of enrolment (except for a type of skin cancer called squamous cell carcinoma)
• People with significant problems affecting the oesophagus or stomach, such as severe acid reflux, a stomach motility disorder, a fungal infection of the oesophagus, or active stomach ulcers
• People with an active infection anywhere in the body at the time of enrolment
• People with untreated severe obstructive sleep apnoea (defined as more than 30 breathing pauses per hour)
• People who need to take certain medications called phosphodiesterase inhibitors within 24 hours before the procedure
• People with a life expectancy of less than one year
• People currently enrolled in another research study or registry that would conflict 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 with congenital (present from birth) heart disease that has left a significant ongoing problem with the heart's structure or electrical system
• People with a known inherited condition called congenital methemoglobinemia
• People with a known inherited enzyme deficiency called G6PD deficiency

For the ELEVATE-COR sub-study specifically, additional criteria apply. People may not be able to join if they:

• Do not meet all of the main trial criteria listed above
• Are not planned to have an additional heart rhythm procedure called CTI ablation
• Are unwilling or unable to take part in all assessments specific to this sub-study
• Already have stents in the right coronary artery and/or the left circumflex artery
• Have known severe coronary artery disease that cannot be treated with procedures to restore blood flow
• Have moderate to severe coronary artery disease that the treating doctor considers would raise the risk of participation too much
• Have a coronary calcium score of 1,000 or higher (a measure of calcium build-up in the heart's arteries)
• Have significantly reduced kidney function or a history of kidney dialysis or transplant (same threshold as the main trial)
• Have a reason they cannot undergo a procedure called IVUS (a type of imaging used inside blood vessels) (confirm with trial site)
• Have a BMI over 35

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