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 between 18 and 80 years old (or over 18 if local rules require it).
• People who have been diagnosed with atrial fibrillation (an irregular heart rhythm) that keeps coming back and has not been controlled by medication — either episodes that last less than 7 days (paroxysmal AF), or episodes lasting between 7 days and 1 year (persistent AF), with specific medical records confirming the diagnosis.
• People whose AF has not responded to at least one heart rhythm medication, who could not tolerate such medication, or who have a medical reason they cannot take it.
• People who are able and willing to give their consent to participate.
• People who are willing and able to attend all required visits, follow-up appointments, and heart rhythm monitoring checks for the full length of the study.
• People with a life expectancy of more than 1 year.

Who may not be able to join:

• People who have a known medical reason why a heart ablation procedure, a throat ultrasound scan (TEE), a CT scan, or blood-thinning medication would not be safe for them — including having a blood clot in the upper left chamber of the heart.
• People whose AF has been continuous for more than 12 months.
• People who have previously had any procedure or surgery on the left side of the heart, including a previous ablation or a procedure to close the left atrial appendage.
• People whose AF is caused by something treatable or reversible, such as a thyroid problem, an electrolyte imbalance, or alcohol use.
• People whose heart pumping strength (left ventricular ejection fraction) is below 35%, as measured within the past 6 months.
• People with severe heart failure symptoms classified as NYHA Class III or IV (confirm with trial site for what this means in your situation).
• People with an enlarged upper left heart chamber (left atrium) beyond a certain size, measured within the past 6 months.
• People who currently have, or are expected to receive, certain implanted heart devices (such as a permanent pacemaker, defibrillator, or certain closure devices) at the time of the procedure.
• People with a body mass index (BMI) over 40.
• People who have not been taking blood-thinning medication for at least 3 weeks before the procedure.
• People who have had heart surgery, a heart attack, or a coronary artery procedure (such as stenting or angioplasty) within the 3 months before enrolling.
• People with significant heart valve disease, a history of heart valve surgery, or an artificial mitral or tricuspid heart valve.
• People with abnormalities or stenting in the pulmonary veins (the blood vessels connecting the lungs to the heart).
• People with primary pulmonary hypertension (high blood pressure in the lung arteries not caused by another condition).
• People with severely uncontrolled high blood pressure (readings above 180 systolic or 110 diastolic at baseline).
• People who already have paralysis of one side of the diaphragm (the main breathing muscle).
• People with significantly reduced kidney function (eGFR below 40), or a history of kidney dialysis or kidney transplant.
• People with rheumatic heart disease.
• People with unstable chest pain or ongoing reduced blood supply to the heart.
• People with certain thickening or stiffening conditions of the heart muscle, including hypertrophic cardiomyopathy or severe left ventricular hypertrophy (heart wall thickness over 15mm).
• People with a history of blood clotting or bleeding disorders (such as thrombocytosis).
• People who have had a stroke, mini-stroke (TIA), or blood clot travelling through the body within the 6 months before enrolling.
• People with an active infection anywhere in the body.
• People with an active cancer, or who have been treated for cancer within the past 12 months (with some exceptions for certain low-risk skin or prostate cancers, or breast cancer with a life expectancy over 1 year — confirm with trial site).
• People who are currently pregnant, breastfeeding, or who may become pregnant during the study follow-up period.
• People who are already enrolled in another clinical study that could affect the results of this trial.
• People who, in the treating doctor's judgement, are unlikely to benefit from an ablation procedure or are considered unsuitable for the study for other medical or personal reasons (such as serious mental illness, terminal illness, or being unable to attend the research centre regularly).

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