Foramen Ovale, Patent Clinical Trial
— STITCHOfficial title:
Suture Mediated Septal Defect Closure/Repair Evaluation of the NobleStitch EL System
Verified date | December 2017 |
Source | HeartStitch.Com |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 250 |
Est. completion date | November 20, 2022 |
Est. primary completion date | November 20, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Inova Cardiovascular Institute | Falls Church | Virginia |
Lead Sponsor | Collaborator |
---|---|
HeartStitch.Com |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Migraine | Rate of Patients who have Experienced Improvement in Migraine | 4-6 weeks, 6 months, 1 year and annually up to five years | |
Primary | Closure Rates of PFO and ASD | Saline Contrast Echo | 12 months | |
Secondary | Recurrent Stroke Rate | Rate of which Patient Experiences Recurrent Stroke | 4-6 weeks, 6 months, 1 year and annually up to five years |
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