NCT03821129

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 636 (estimated)
• Sponsor: W.L.Gore & Associates · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Stroke
• PFO - Patent Foramen Ovale

Interventions

Type	Name	Description
DEVICE	PFO closure with GORE® CARDIOFORM Septal Occluder	PFO closure with GORE® CARDIOFORM Septal Occluder in patients with ischemic stroke

Timeline

• Start date: 2019-07-25
• Primary completion: 2028-10-01
• Completion: 2031-10-01
• First posted: 2019-01-29
• Last updated: 2025-09-11

Locations

44 sites across 1 country: United States

Regulatory

• FDA-regulated device study