Stroke 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 18 to 65 years old
• People who have been diagnosed with a patent foramen ovale (PFO) — a small opening between the upper chambers of the heart — confirmed by a specific type of ultrasound test called a TEE (a camera passed down the throat to look at the heart)
• People who have had an ischemic stroke (where a blood clot blocks blood flow to the brain), confirmed by an MRI or CT scan
• People whose stroke has left them with mild to moderate disability, as measured by a standard medical scoring system called the Modified Rankin Scale (score of 3 or below)
• People whose heart anatomy is suitable for the device being tested, as assessed by an independent medical committee
• People who are willing and able to give their informed consent to participate
• People of childbearing potential who have a negative pregnancy test taken within 7 days before the procedure

Who may not be able to join:

• People whose stroke appears to have been caused by something other than the PFO, such as plaques in the main blood vessel leaving the heart, blockages in large arteries near the brain, other known heart-related causes of stroke, disease in small blood vessels, or a torn artery
• People with a blood clot in a small pouch attached to the upper-left chamber of the heart (left atrial appendage)
• People with significant narrowing (more than 50%) in blood vessels supplying the area of the brain affected by the stroke
• People with a blood clot or tumour inside the heart
• People who have had a heart attack or severe chest pain (unstable angina) within the past 180 days (about 6 months)
• People with a life expectancy of less than 2 years
• People with certain structural problems with the left side of the heart, such as a bulging or non-moving area of the heart wall
• People with moderate to severe narrowing of the mitral heart valve, or severe leaking of the mitral valve
• People with significant narrowing or severe leaking of the aortic heart valve
• People with an active heart infection or other active infection that could make implanting the device unsafe
• People with abnormal growths on any of the left-sided heart valves
• People with a weakened, enlarged heart where the heart's pumping function is significantly reduced (pumping less than 35% of blood per beat)
• People who have another identified cause of blood flowing the wrong way through the heart, such as a different type of hole in the heart or abnormal blood vessels in the lungs
• People with a history of certain irregular heart rhythms, or who require a pacemaker or a device to correct dangerous heart rhythms
• People with severely reduced kidney function or who require dialysis
• People with severe liver disease, such as cirrhosis or active hepatitis
• People with severe lung problems who need ongoing oxygen or long-term steroid medications
• People with uncontrolled high blood pressure (consistently above 140/90 mmHg)
• People with severely high blood pressure in the arteries of the lungs
• People with poorly controlled blood sugar levels (as measured by a specific blood test called HbA1c above 8%)
• People at high risk of bleeding, including those with a history of serious bleeding episodes such as bleeding in the gut, eyes, or brain, or those with clotting disorders
• People with a known condition causing the blood to clot too easily, which would require ongoing blood-thinning medication
• People who cannot take the medications aspirin or clopidogrel (blood-thinning tablets)
• People who need to remain on blood-thinning medication for reasons unrelated to the stroke
• People with any other serious illness that, in the doctor's judgement, could interfere with safely completing the trial — for example, certain cancers
• People currently participating in another clinical trial of an experimental drug or device that could affect this trial's results
• People with significant heart valve problems that make the PFO closure procedure unsafe, or with severely raised pressure in the lung's blood vessels
• People for whom the ultrasound procedure used to guide the device (TEE or ICE) is not safe or suitable
• People who have previously had a procedure to treat an irregular heart rhythm called atrial fibrillation (AF ablation)

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