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:

• Adults between 18 and 60 years of age.
• People who are able to understand the purpose of the trial and are willing to participate and sign a consent form.
• People who have been confirmed to have a patent foramen ovale (a small opening between the upper chambers of the heart that did not close after birth) through at least one heart imaging test, such as a transthoracic or transoesophageal echocardiogram (ultrasound of the heart).
• People confirmed to have a medium or large blood flow crossing from the right side to the left side of the heart, detected through a special contrast ultrasound test.
• People whose condition meets the medical criteria for closing a patent foramen ovale, and who also meet at least one of the following situations:
  • A stroke with no known cause, linked to a patent foramen ovale, plus one or more recognised clinical risk factors.
  • A stroke with no known cause, linked to a patent foramen ovale, plus one or more structural risk features of the opening itself.
  • A stroke with no known cause, linked to a patent foramen ovale, along with confirmed blood clots in the legs or lungs, where blood-thinning medication is not suitable.
  • A stroke with no known cause, linked to a patent foramen ovale, where a further stroke occurred even while taking blood-thinning or anti-clotting medication.

Who may not be able to join:

• People found to have significant narrowing of the carotid arteries (the main blood vessels in the neck) of more than 50%, as determined by a CT scan or ultrasound.
• People who had a large stroke within the past 4 weeks, based on brain imaging results showing significant damage.
• People who have blood clots, tumours, or abnormal growths inside the heart.
• People who had a heart attack or severe unstable chest pain within the past 6 months.
• People with a bulging area of the heart's left lower chamber, or abnormal movement of the heart wall.
• People with significant disease of the mitral or aortic heart valves, including narrowing, severe leakage, abnormal growths on the valves, or a history of heart valve replacement surgery.
• People with an enlarged and weakened heart muscle, a heart pumping function below 35%, or other serious heart failure conditions.
• People whose blood flows from right to left through a different heart defect, such as a hole between the upper chambers (atrial septal defect) or another structural abnormality.
• People with atrial fibrillation or atrial flutter (irregular heart rhythms), whether constant or occurring from time to time.
• People who are pregnant or planning to become pregnant during the trial period.
• People with active infection of the heart lining, other untreated infections, or conditions that cause abnormal bleeding.
• People with high blood pressure in the lungs (pulmonary hypertension), or where the patent foramen ovale serves a specific functional role in the body (confirm with trial site).
• People with significantly reduced liver or kidney function, based on specific blood test results exceeding set limits.
• People with uncontrolled high blood pressure above 180/100 mmHg.
• People who cannot safely take blood-thinning or anti-clotting medications — for example, those who have had serious bleeding within the past 3 months, significant eye disease due to blood vessel problems, a history of bleeding in the brain, or other significant brain conditions.
• People whose heart disease, high blood pressure, diabetes, or other blood vessel conditions are not well managed despite treatment.
• People whom the investigating doctor determines are not suitable candidates for the heart closure device procedure, for example due to the specific size or shape of the heart anatomy.
• People who have a blood clot at or along the path where the device would need to be placed.
• People with cancer or another condition where life expectancy is estimated to be less than 2 years.
• People who would be unable to attend follow-up visits during the trial.
• People who have participated in another clinical trial of a drug or medical device within the past 3 months.

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