GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients with Patent Foramen Ovale fPFO): the REDUCE Post Approval Study

View GORE® GSO 18-01 PAS information 

This is a post market approval study for prevention of additional stroke. Every subject has device implanted post Cryptogenic Stroke to close PFO. Device is approved and paid for by both insurance and Medicare. Standard of Care currently followed for patients. 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.

Primary Investigator: Michael Cinquegrani, MD
Subinvestigators: Michael Salinger, MD; David S. Marks, MD, MBA

ClinicalTrials.gov Identifier: NCT03821129

Status: Currently enrolling
Sub Category: Structural Heart

View GORE® CARDIOFORM information

The purpose of the GORE® CARDIOFORM Septal Occluder (GSO device) post approval study is to assess the safety and effectiveness of the GSO device as observed in the REDUCE pivotal IDE study, and to evaluate the quality of operator education and training and transferability of trial experience to a post-market setting.

Primary Investigator: Michael Cinquegrani, MD
Subinvestigators: Diane Book, MD; David Marks, MD, MBA; Michael Salinger, MD; Nicole Lohr, MD, PhD

ClinicalTrials.gov Identifier: NCT03821129

Status: Currently Enrolling
Sub Category: Structural Heart Disease