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 persistent atrial fibrillation (an irregular heart rhythm that has lasted more than 7 days but less than 365 days), confirmed by a doctor's note and either two heart tracings (ECGs) taken at least 7 days apart, or a 24-hour heart monitor recording, all done within the past year.
• People who are between 18 and 80 years of age at the time of signing the consent form.
• People who are willing and able to give their informed consent to participate.
• People who are able and willing to attend all required appointments and follow-up visits before, during, and after the trial.
• For a specific sub-group of this trial: people whose doctor has determined they are clinically suited for a procedure to close off a small pouch in the heart called the left atrial appendage.

Who may not be able to join:

• People whose atrial fibrillation has been continuous for more than 365 days (sometimes called longstanding persistent AF).
• People whose irregular heart rhythm is caused by something other than the heart itself, such as a thyroid condition, an electrolyte imbalance, untreated sleep apnea, or alcohol-related causes.
• People who have previously had surgery or a catheter-based procedure to treat atrial fibrillation.
• People who are known to need a specific type of heart rhythm treatment in areas of the heart outside those targeted in this trial (confirm with trial site).
• People whose left upper heart chamber (left atrium) is severely enlarged, based on imaging done within the past 180 days.
• People who have a blood clot in the left upper heart chamber, confirmed by imaging taken within 48 hours before the procedure.
• People whose heart's main pumping chamber is significantly weakened (pumping less than 40% of its normal capacity), confirmed by imaging within the past 180 days.
• People with severe or uncontrolled heart failure, including those classified as having the most serious levels of heart failure symptoms (Class III or IV).
• People with a history of blood clotting disorders, abnormal bleeding, or who cannot safely take blood-thinning medications such as heparin.
• People who have had a stroke, mini-stroke (TIA), or other blood clot-related event within the past 180 days.
• People who have had a heart attack or a procedure to open blocked heart arteries (such as a stent) within the past 60 days.
• People who have had open-heart bypass surgery within the past 180 days.
• People who have had heart valve surgery or a valve procedure, or who have an artificial heart valve.
• People who have had unstable chest pain (unstable angina) within the past 6 months.
• People who are expected to need a heart transplant, heart surgery, or another major surgery within 365 days after the trial procedure.
• People with serious lung disease or other significant lung or breathing problems that cause severe ongoing symptoms.
• People with significant heart or structural abnormalities present from birth (including those that have been repaired), where the trial doctor determines these would prevent safe participation.
• People who already have a diagnosis of narrowing of the pulmonary veins (the blood vessels connecting the lungs to the heart).
• People who already have paralysis of one side of the diaphragm (the main breathing muscle).
• People who currently have an acute illness, active infection, or blood infection (sepsis).
• People who have a blood clot, tumour, abnormal growth, or other structural problem inside the heart that would prevent safe use of the required catheters (thin tubes used during the procedure).
• People with severe leaking of the heart's mitral valve, based on specific measurements (confirm with trial site).
• People who have a metal device implanted in or around the heart (other than coronary stents, pacemakers, defibrillators, or implantable loop recorders) 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, such as a filter in the large vein in the abdomen.
• People who are currently taking part in another clinical trial involving an experimental device or drug.
• People who are pregnant, breastfeeding, or who are able to become pregnant and plan to try to do so during the trial.
• People whose life expectancy is less than 365 days.
• People who have any medical reasons that rule out the use of the specific devices involved in this trial, as outlined in the official device instructions.
• People who have medical reasons that rule out the specific heart rhythm treatment targeting a particular blood vessel (the superior vena cava) in this trial.
• For the sub-group involving the heart pouch closure procedure: people for whom that specific procedure is not medically appropriate according to the device's official instructions, or people who have previously had that procedure attempted or completed.

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