Clinical Trial: Heart and Vascular, Neurology

Gore: Stroke (REDUCE Post Approval Study)

Full Name

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

Description

Purpose: The purpose of the GORE® CARDIOFORM Septal Occluder (GSO device) post-approval study is to assess the safety and effectiveness of GSO device in people who will need to have this device implanted.

This is a prospective, multicenter, open label, single-arm study to confirm and describe the safety and effectiveness of the GSO device. When a person has a stroke, part of the work-up to determine the cause of the stroke is obtain an image of the heart called an echocardiogram. If the echocardiogram shows a patent foramen ovale, or PFO, a small flap in the heart separating the left and right atria found in ¼ of all people-the doctors may recommend the person to go for a catheterization procedure to have the PFO closed. While not all PFOs result in stroke, if all other sources of a clot have been ruled out, the current data suggests that a clot could come from the PFO, therefore necessitating its closure.

All participants who participate in Gore Stroke (REDUCE PAS) will receive the exact same care and treatment they would outside of the study. However, it is requested that all participants adhere to the routine treatment and follow-up schedule for all participants who undergo PFO closure, including follow-up visits at study specific timepoints. Participation in this study will last up to 5 years

Eligibility

Inclusion Criteria
  1. Between the ages of 18-70
  2. Evaluation prior to participation by a neurologist and is diagnosed with an ischemic stroke presumed to be an embolic stroke of undetermined source (ESUS) within the last year prior to enrollment
  3. Presence of a PFO, as determined diagnostic testing
  4. Able to tolerate antiplatelet therapy

To Participate:
Please contact the Network Office of Research and Innovation at 610-402-9543

For more information: https://www.clinicaltrials.gov/ct2/show/NCT03821129?term=NCT03821129&draw=2&rank=1