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 between 18 and 85 years old
• People who are willing and able to give informed consent and attend all required follow-up visits as set out in the study plan
• People who have a documented history of atrial fibrillation (an irregular heart rhythm) — either the type that comes and goes and stops within 7 days, or the type that lasts longer than 7 days and needs treatment — within the past year, confirmed by a heart tracing or monitoring record
• People who are already scheduled for a planned (non-emergency) open-heart surgery using a heart-lung bypass machine, for one or more of the following: mitral valve repair or replacement, aortic valve repair or replacement, repair of an aortic aneurysm, repair of a hole in the heart (ASD or PFO), or coronary artery bypass surgery
• People whose heart pumping function is at least 30%, as measured by a heart scan done within 60 days before joining the study
• People who are expected to live for at least 5 more years
• People who live close enough to the study site to attend visits and plan to stay in the area for at least 12 months

Who may not be able to join:

• People who have an implanted heart device such as a pacemaker, defibrillator, cardiac resynchronisation device, or a left atrial appendage closure device
• People who have, or are known to have, a blood clot in the left atrial appendage (a part of the heart)
• People who already have an artificial heart valve
• People whose only reason for surgery is atrial fibrillation, with no additional need for bypass or valve surgery
• People who have had any prior heart surgery, including a previous surgical procedure to treat atrial fibrillation
• People whose left atrium (a chamber of the heart) measures 6 cm or larger
• People with certain other heart rhythm conditions, including Wolff-Parkinson-White syndrome or related arrhythmias
• People with a documented history of persistent atrial fibrillation lasting longer than 10 years
• People requiring surgery for reasons other than those listed in the inclusion criteria (confirm with trial site)
• People who have previously had a procedure involving instruments being used inside the left atrium, such as a prior catheter ablation
• People currently taking anti-arrhythmic medication specifically for a ventricular (lower heart chamber) rhythm problem
• People whose surgical risk score (STS Predicted Risk of Mortality) is 10 or higher
• People with severe heart failure symptoms classified as Class III or IV by standard heart failure guidelines
• People who have had a stroke within the past 6 months
• People who have had a heart attack (with ST-segment elevation on heart tracing) within the past 6 weeks
• People who need emergency heart surgery
• People with a known blockage of more than 80% in the carotid arteries (the main arteries in the neck)
• People with a currently active, systemic (whole-body) infection
• People with severe narrowing of the arteries in the legs causing pain with minimal walking
• People with kidney failure requiring dialysis, or significant liver failure
• People with a known addiction to drugs or alcohol
• People with a mental health condition or other circumstances that may prevent them from fully understanding the study
• People who are pregnant or plan to become pregnant within 12 months of the study treatment
• People who need a heart pump device or intravenous heart-strengthening medications before surgery
• People who have previously received radiation treatment to the chest area
• People currently undergoing chemotherapy
• People on long-term oral or injected steroid medication (not including inhaled steroids used occasionally for breathing conditions)
• People with a known condition called hypertrophic obstructive cardiomyopathy (a specific type of thickened heart muscle)
• People with a known condition called cold agglutinin (a blood condition)
• People who cannot safely take blood-thinning medication due to a bleeding or clotting disorder
• People who have had an organ or blood cell transplant, or who are currently being assessed for one
• People with a body mass index (BMI) greater than 45
• People with any diagnosed connective tissue disorder
• People with severe chronic obstructive pulmonary disease (COPD), as defined by standard surgical risk criteria
• People who have participated in another research study or used another investigational treatment within the past 30 days, or who are currently in another study

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