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The purpose of the STITCH study is to evaluate closure rates of clinically relevant septal defects, including patent foramen ovale (PFO), Atrial Septal Defects (ASD - less than 1 cm with redundant septal tissue), trans septal puncture sites, repair of Atrial Septal Aneurysm (ASA) and rate of recurrent neurologic embolic events in patients with cryptogenic stroke and PFO.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PFO Closure Rate | Other | Evaluate closure rate of clinically relevant septal defects including PFO, ASD (less than 1 cm with redundant septal tissue), trans septal puncture sites, repair of ASA (when an appropriate PFO or small ASD defect is present) and rate of recurrent neurologic embolic event in patients with cryptogenic stroke and PFO |
|
| Published PFO Device Closure | Other | Compare PFO closure rate and safety of closure of septal occluders in published PFO clinical trials. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PFO Closure Rate | Device | Suture Mediated PFO Closure and Septal Repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| Closure Rates of PFO and ASD | Saline Contrast Echo | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent Stroke Rate | Rate of which Patient Experiences Recurrent Stroke | 4-6 weeks, 6 months, 1 year and annually up to five years |
| Measure | Description | Time Frame |
|---|---|---|
| Migraine | Rate of Patients who have Experienced Improvement in Migraine | 4-6 weeks, 6 months, 1 year and annually up to five years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Thompson, MD | Inova Cardiovascular Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inova Cardiovascular Institute | Falls Church | Virginia | 22042 | United States |
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| ID | Term |
|---|---|
| D054092 | Foramen Ovale, Patent |
| D006344 | Heart Septal Defects, Atrial |
| D006343 | Heart Septal Defects |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
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Non-randomized, single-center, observational study
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| Published PFO Device Closure | Device | Suture Mediated PFO Closure and Septal Repair |
|
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |