458 Studies Now Enrolling
GORE CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval Study
A Study of GORE CARDIOFORM Septal Occluder for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO)
| Sponsor: | W.L.Gore & Associates |
| Enrolling: | Male and Female Patients |
| IRB Number: | AAAS3126 |
| U.S. Govt. ID: | NCT03821129 |
| Contact: | Kate Dalton: 347-514-3366 / keb2114@cumc.columbia.edu |
Additional Study Information:
This is a prospective, multicenter, open-label, single-arm study that seeks to confirm and describe the safety and effectiveness of the GSO device as observed in the REDUCE pivotal IDE study. It is also designed to demonstrate acceptable performance of the GSO device in patients treated with percutaneous, transcatheter PFO closure plus anti-platelet medical management compared to performance goals derived from REDUCE study results.
Do You Qualify?
| Have you been recently diagnosed with a stroke of unknown origin (cryptogenic stroke) confirmed by MRI? | Yes | No |
| Do you have a hole in the heart (PFO) as confirmed with echocardiograph? | Yes | No |
| Do you have a history of or on-going atrial fibrillation/flutter? | Yes | No |
| Are you between 18-70 years old? | Yes | No |