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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

NCT03821129 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 636

Last updated 2026-05-05

No results posted yet for this study

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.

Conditions

  • Stroke
  • PFO - Patent Foramen Ovale

Interventions

DEVICE

PFO closure with GORE® CARDIOFORM Septal Occluder

PFO closure with GORE® CARDIOFORM Septal Occluder in patients with ischemic stroke

Sponsors & Collaborators

  • W.L.Gore & Associates

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-25
Primary Completion
2028-10-31
Completion
2031-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03821129 on ClinicalTrials.gov