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 thesafety 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 withpercutaneous, transcatheter PFO closure plus anti-platelet medical management compared toperformance goals derived from REDUCE study results.
Investigator
Robert Sommer, MD
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
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You may be eligible for this study

Place Holder




For more information, please contact:
Kate Dalton
keb2114@cumc.columbia.edu
347-514-3366