Navigation> Stroke TIA PFO Connection Your Heart CLOSURE I Trial

The CLOSURE I trial will compare the effectiveness (in terms of preventing stroke or TIA recurrence) of permanent PFO closure with the STARFlex® septal repair implant against conventional medications in 900 patients. It is designed to determine which form of care is superior.

How does the trial work? (back to top)

The patients enrolled into the trial will be allocated to one of two groups or “study arms” – the device “arm” and the medical therapy “arm”. This allocation is done by computer and is entirely random. There is an equal chance of being in either “arm”. This allocation process of patients to one arm or the other is called randomization.

How are the two study arms different? (back to top)

The medical therapy arm will receive standard medication (warfarin, aspirin, or both) for 24 months. The device arm will have their PFO permanently closed using the STARFlex® septal repair implant. They will be required to take clopidogrel (Plavix) for 6 months and aspirin for 24 months after closure.

What follow-up is required? (back to top)

All patients Follow-up is required at one, six, twelve and twenty-four months after enrollment in the study. The one month follow-up is a phone interview. The remainder require an office visit with the study neurologist. If any patient experiences a stroke or TIA during the study period, they will need to have a magnetic resonance imaging (MRI) test. There may also be other tests needed, which will be determined by the study neurologist. Device arm Patients in the device arm of the study will also need to see the interventional cardiologist who implanted the STARFlex® six months after the procedure. This visit will involve a chest X-ray and a TEE test. Depending on the results of these tests, further visits may be required. Medical therapy arm Patients in the medical therapy arm taking warfarin will have to have their pro- thrombin (clotting time) rates checked weekly against international normalization ratios (INRs) until a therapeutic level of between 2.0 and 3.0 is established, then every month after that. This is a simple blood test measuring the number of seconds if takes for an individual’s blood to clot. Patients taking aspirin will not need any special testing.

Who can be included? (back to top)

The trial will include patients who:

• Have suffered either a stroke or transient ischemic attack (TIA) within the last six months and who have a patent foramen ovale (PFO).
• Have no other cardiac or vascular condition which could be a cause of stroke (e. g. carotid artery).
• Are aged between 18 and 60 years.
• Have no requirement for chronic warfarin administration outside the requirements of the CLOSURE I study.

If you think you, or someone you may know, might be a candidate, please contact NMT Medical or a participating neurologist near you. Clinical Trial Sites.

What is the implant being used? (back to top)