Atrial Fibrillation Trial, Recruiting

Written by an AI model from the 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 are already scheduled and medically approved for open-heart surgery that requires the use of a heart-lung bypass machine and opening of the sac surrounding the heart.
• People who are 65 years of age or older and have a stroke risk score (called CHA2DS2-VASc) of 3 or higher (confirm with trial site).

Who may not be able to join:

• People with a documented history of atrial fibrillation (an irregular heartbeat) or atrial flutter at any time before the planned surgery.
• People who have previously had any surgery or procedure that involved opening or entering the sac surrounding the heart.
• People whose planned surgery will be performed without the use of a heart-lung bypass machine (called "off-pump" surgery).
• People who have previously had the left atrial appendage (a small pouch in the heart) blocked, removed, or closed off, either surgically or through a non-surgical procedure.
• People who have a permanent pacemaker already in place.
• People with a condition where abnormal proteins or other substances build up in the heart muscle, such as amyloidosis.
• People whose planned surgery will be performed through an approach other than a standard chest-opening (sternotomy) incision.
• People whose planned surgery is a heart transplant or the long-term implantation of a device to help the heart pump blood.
• People who have abnormal heart rhythms originating in the lower chambers of the heart (ventricular arrhythmia).
• People with an active infection of the inner lining of the heart (endocarditis).
• People with the most severe level of heart failure symptoms (classified as NYHA Class IV), meaning significant symptoms even at rest.
• People who require a mechanical heart-assist balloon pump or intravenous medications to support heart function before surgery.
• People who have an active infection anywhere in the body at the time of surgery that requires antibiotic treatment.
• People with a known allergy to Nitinol (a metal alloy) or sensitivity to nickel.
• People with a known medical condition where life expectancy is less than one year.
• People with other health conditions that, in the opinion of the trial investigator, would make completing the trial's required procedures or visits unsuitable for them.
• People who are currently enrolled in another clinical trial involving an investigational device or drug that could interfere with this trial.
• People with significant mental impairment or psychiatric conditions that may prevent them from fully understanding the nature and requirements of the trial.
• People who are pregnant.
• People with known severe symptomatic carotid artery disease (a serious narrowing of the main arteries in the neck).

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