Foramen Ovale, Patent Clinical Trial
Official title:
Suture Mediated Septal Defect Closure/Repair Evaluation of the NobleStitch EL System
Verified date | August 2023 |
Source | Nobles Medical Technologies II Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
STITCH - Prospective Multi-Center Comparative Parallel Concurrent Study of the NobleStitch™ EL versus FDA approved Amplatzer Occluder device for closure of Patent Foramen Ovale to prevent recurrent ischemic stroke.
Status | Enrolling by invitation |
Enrollment | 640 |
Est. completion date | January 31, 2026 |
Est. primary completion date | June 30, 2024 |
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 years and over 65 years of age - Patients who are not fluent in English |
Country | Name | City | State |
---|---|---|---|
Italy | Ospedale S. Eugenio | Rome | Lazio |
United States | Inova Structural Heart Disease Program - Fairfax | Fairfax | Virginia |
United States | Tampa General Hospital | Tampa | Florida |
United States | TMC HealthCare | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
Nobles Medical Technologies II Inc |
United States, Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Migraine | Rate of Patients who have Experience 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 annualy up to five years |
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