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

Conditions

• PFO - Patent Foramen Ovale
• Stroke

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Jul 25, 2019

Status verified

Apr 2026

Primary completion

Oct 31, 2028

Completion

Oct 31, 2031

Study Design

Enrollment

636 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Arms

• Other: GORE® CARDIOFORM Septal Occluder
  Single Arm Commercially available GORE® CARDIOFORM Septal Occluder

Primary Outcome Measure

Proportion of subjects with recurrent ischemic stroke post study device implant (Primary Effectiveness Outcome) [ Time Frame: 24 months ]

Central Contacts

• Tammy DeLozier
  800-437-8181
  [email protected]

Locations (45)

Find similar trials in Tucson, AZ

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