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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 — REDUCE PAS  

Stroke Clinical Trial

Official title:
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

Clinical Trial Summary

This study will assess the safety and effectiveness of GORE® CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a post-market setting.

Clinical Trial Description

A maximum of 636 adult subjects will be enrolled at up to 40 U.S. centers. Subjects will have follow-up at 1 month, 6 months, 12 months and annually thereafter through 5 years post implant. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03821129
Study type Interventional
Source W.L.Gore & Associates
Contact Tammy DeLozier
Phone 800-437-8181
Email GSO1801@wlgore.com
Status Recruiting
Phase N/A
Start date July 25, 2019
Completion date December 2029
View Details
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