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 have been diagnosed with symptomatic paroxysmal atrial fibrillation (AF), meaning AF episodes that come and go and cause noticeable symptoms.
• People who have had at least two symptomatic AF episodes in the last six months before joining the trial.
• People who have had at least one AF episode confirmed by a heart tracing (such as an ECG) within the 12 months before joining.
• People who have already tried at least one heart rhythm medication (from a specific category of drugs used to control abnormal heart rhythms) that did not work well enough.
• People who are willing and able to give their informed consent to take part.
• People who are able and willing to attend all required visits and complete all testing before, during, and after the trial.

Who may not be able to join:

• People who have previously been diagnosed with persistent AF, meaning AF episodes that lasted longer than 7 days.
• People whose AF is caused by an imbalance of body salts, a thyroid condition, or another reversible or non-heart-related cause.
• People who have previously had a surgical or catheter-based procedure to treat their AF.
• People whose condition is known to require treatment in areas of the heart beyond the specific regions this trial focuses on (confirm with trial site).
• People whose left heart chamber (left atrium) has been shown by imaging to be severely enlarged (above a certain measurement) within the last 6 months.
• People who have been found to have a blood clot in their left heart chamber on imaging taken within 48 hours of the planned procedure.
• People whose heart's pumping strength has been found to be severely reduced on imaging within the last 6 months.
• People with uncontrolled heart failure, or heart failure that severely limits physical activity or causes symptoms at rest.
• People with a history of blood clotting or bleeding problems, or for whom blood-thinning medications are not safe to use.
• People who have had a blood clot-related event, including a mini-stroke (TIA), within the past 6 months.
• People who have had a heart procedure to open blocked arteries (PCI) or a heart attack within the past 2 months.
• People who have had coronary bypass heart surgery within the past 6 months.
• People who have previously had surgery or a procedure on a heart valve.
• People who have experienced unstable chest pain (unstable angina) within the past 6 months.
• People who are expected to need a heart transplant, heart surgery, or other major surgery within the next 12 months.
• People with significant lung disease or another serious lung or breathing condition that causes severe ongoing symptoms.
• People with a significant birth defect or medical condition that, in the trial doctor's opinion, would prevent safe participation.
• People who have previously been diagnosed with narrowing of the pulmonary veins (the blood vessels connected to the heart that this procedure targets).
• People who already have partial paralysis of the diaphragm (the main breathing muscle).
• People who are currently experiencing an acute illness, active widespread infection, or blood poisoning (sepsis).
• People who have a blood clot, tumour, abnormal growth, or structural abnormality inside the heart that would make the procedure unsafe or impossible.
• People with severe leaking of the heart's mitral valve.
• People who have an implanted pacemaker, defibrillator (ICD), or other implanted metal heart device (other than coronary stents) that could interfere with the energy used in the procedure.
• People who have a condition that prevents safe access to the blood vessels needed for the procedure.
• People who are currently taking part in another clinical trial testing a different device or drug.
• People who are pregnant (confirmed by a pregnancy test where applicable), breastfeeding, or of childbearing age and planning to become pregnant during the trial.
• People whose life expectancy is less than 12 months.
• People for whom the specific devices used in this trial are considered unsafe based on the manufacturer's instructions.

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