Foramen Ovale, Patent, Septal Defect, Atrial, Septal Defect, Heart
Conditions
Brief summary
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.
Interventions
DEVICEPFO Closure Rate
Suture Mediated PFO Closure and Septal Repair
DEVICEPublished PFO Device Closure
Suture Mediated PFO Closure and Septal Repair
Sponsors
HeartStitch.Com
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Non-randomized, single-center, observational study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Closure Rates of PFO and ASD | 12 months | Saline Contrast Echo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrent Stroke Rate | 4-6 weeks, 6 months, 1 year and annually up to five years | Rate of which Patient Experiences Recurrent Stroke |
Other
| Measure | Time frame | Description |
|---|---|---|
| Migraine | 4-6 weeks, 6 months, 1 year and annually up to five years | Rate of Patients who have Experienced Improvement in Migraine |
Countries
United States
Outcome results
None listed