Stitch Closure of PFO and Septal Repair
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 12/16/2017 |
| Start Date: | November 20, 2017 |
| End Date: | November 20, 2022 |
Suture Mediated Septal Defect Closure/Repair Evaluation of the NobleStitch EL System
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.
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.
Inclusion Criteria:
- PFO
- ASD (less than 1 cm with redundant septal tissue)
- Trans Septal Puncture Sites
- ASA (when an appropriate PFO or small ASD defect is present)
- Stroke
- Trans ischemic Attack (TIA)
- Platypnea Orthodeoxia Syndrome
- Decompression Illness
Exclusion Criteria:
- Patients under 18 and over 65
- Patients who are not fluent in English
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