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:

• You have had a stroke caused by a blood clot that traveled to the brain (linked to an irregular heart rhythm called atrial fibrillation), even while taking blood thinners, within the last 6 months.
• You have a confirmed diagnosis of atrial fibrillation (AF) — any type.
• The small pouch in your heart (called the left atrial appendage, or LAA) is suitable for a closure procedure (even if a clot is present in certain positions — confirm with trial site).
• You are able to carry out daily activities without severe disability (your disability level must be below a certain threshold — confirm with trial site).
• You are able to have a heart scan using CT or a special ultrasound (3D-TEE) with no medical reasons preventing this.
• You are over 18 years old.
• Your life expectancy is more than 1 year.
• You are able to read and understand the consent form before joining the trial.
• You are able and willing to attend follow-up visits and tests as required.

Who may not be able to join:

• You have a medical reason that means you absolutely cannot take any blood thinners.
• You missed more than a certain number of blood thinner doses in the week before your stroke (confirm with trial site for exact details).
• Your stroke was a specific type called a "lacunar" stroke (a small stroke in a deep part of the brain).
• You have a significant narrowing (more than 50%) of a major artery in your neck (carotid artery) that has been causing symptoms such as brief vision loss or mini-strokes on the same side.
• You are scheduled for a heart operation or invasive procedure requiring sedation or anaesthesia within 3 months of joining the trial (not including procedures that are part of this study).
• Your doctor considers you to be at high risk from general anaesthesia, and general anaesthesia is planned for your study procedure.
• You have an untreated hole in the heart (called a patent foramen ovale, or PFO), or you already have a PFO closure device in place.
• You have a filter placed in a large vein in your abdomen (inferior vena cava filter).
• You have any condition that would normally prevent a catheter-based (thin tube through a blood vessel) procedure — for example, active infection or a bleeding disorder.
• You have a condition that prevents a throat ultrasound (TEE) scan — for example, varicose veins in your oesophagus, a narrowed oesophagus, or a history of oesophageal cancer.
• You had a catheter-based treatment for your irregular heart rhythm within the last 60 days.
• You had a heart attack within the last 90 days.
• You have very severe heart failure (the most advanced stage, known as New York Heart Association Class IV).
• Your heart's pumping strength is very low (30% or less on your most recent test).
• Your left atrial appendage has already been closed off or surgically tied shut.
• You have a very low platelet count or severe anaemia that requires blood transfusions.
• You are allergic to any materials used in the specific closure device being studied (for example, nickel allergy).
• You are allergic to contrast dye used in CT scans, and you also cannot have a throat ultrasound (TEE) scan.
• You are currently taking part in, or plan to join, another clinical trial whose treatment could affect the results of this study.
• You are pregnant, breastfeeding, or planning to become pregnant during the study.
• You have an active heart infection (endocarditis) or another infection that has spread to the bloodstream.
• You have other medical, physical, social, or psychological conditions that, in your doctor's opinion, would prevent you from safely participating or completing the study (confirm with trial site).

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