Stroke 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 have been diagnosed by a neurologist with an ischemic stroke that is believed to have come from an unknown source (called an embolic stroke of undetermined source, or ESUS), within the past 365 days before joining the trial.
• People who have a small natural opening in the heart called a Patent Foramen Ovale (PFO), confirmed by specific heart imaging tests that show blood moving in an abnormal direction through that opening.
• People who are able to take blood-thinning medications called antiplatelet therapy without serious problems.
• Additional inclusion criteria may also apply (confirm with trial site).

Who may not be able to join:

• People who have a history of, or currently have, an irregular heart rhythm called atrial fibrillation or atrial flutter.
• People who have certain other serious health conditions, including blood clots in the heart wall, a weakened or enlarged heart, artificial heart valves, severe heart valve disease, serious problems with how the heart wall moves, a tear in the main blood vessel from the heart, significant artery disease, blood vessel inflammation, pre-existing brain or nervous system disorders unrelated to stroke, abnormal blood vessel connections in the lungs, a previous bleed in the brain, severe disability from a previous stroke, certain immune system disorders, a heart pumping function below 40%, or other abnormal openings in the heart (confirm with trial site for the full list).
• People who have previously had a heart attack.
• People who have significant disability at the time of the procedure, as measured by a standard stroke disability scale score of 3 or higher.
• People who have an active infection that cannot be treated and cleared before joining the trial.
• People who have neurological symptoms or conditions unrelated to stroke that could affect how their nervous system is assessed during the trial.
• People who have a condition causing the blood to clot too easily, uncontrolled diabetes, uncontrolled high blood pressure, or high blood pressure in the lungs at the time of screening or the procedure.
• People who have an allergy to, or a medical reason preventing them from taking, all of the proposed medications or any materials in the device being studied.
• People who are pregnant, breastfeeding, or planning to become pregnant at any point up to 24 months after joining the trial.
• People whose heart anatomy is not suitable for placement of the device used in this trial, including those with complex congenital heart defects or an opening considered too large for the device to close.
• People whose heart structure is expected to require more than one of the closure devices studied in this trial.
• People who need another heart procedure performed at the same time, which could make it harder to tell if any side effects are related to the device.
• Additional exclusion criteria may also apply (confirm with trial site).

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