Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING NA

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 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DEVICE PFO closure with GORE® CARDIOFORM Septal Occluder

Study Locations (20)

California

  • Scripps Health La Jolla — La Jolla
  • Loma Linda University Health — Loma Linda
  • University of California - San Francisco — San Francisco
  • Santa Barbara Cottage Hospital — Santa Barbara

Florida

  • Baptist Health Jacksonville — Jacksonville
  • Naples Community Hospital — Naples
  • Cleveland Clinic Florida — Weston

Illinois

  • Rush University Medical Center — Chicago
  • Alexian Brothers Medical Center — Elk Grove Village
  • Northwestern University — Evanston

Colorado

  • South Denver Cardiology Associates — Littleton
  • Medical Center of the Rockies — Loveland

Iowa

  • University of Iowa Hospitals & Clinic — Iowa City
  • Catholic Health Initiatives- Iowa Corp dba Iowa Heart — West Des Moines

Michigan

  • University of Michigan — Ann Arbor
  • William Beaumont Hospital — Royal Oak

Arizona

  • St. Mary's Hospital — Tucson

Connecticut

  • Yale University School of Medicine — New Haven

Trial Details

FieldValue
Enrollment Target 636 participants
Start Date 2019-07-25
Est. Completion 2031-10
Phase NA

Sponsor

W.L.Gore & Associates

117 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03821129

The ClinicalTrials.gov registry entry for NCT03821129 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 636 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is W.L.Gore & Associates, which has 117 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Stroke appearing as the primary indexed condition, and to 1 intervention — of which PFO closure with GORE® CARDIOFORM Septal Occluder is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03821129 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03821129 about?

NCT03821129 is a clinical study titled "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". 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.

What is the current status of trial NCT03821129?

This trial is currently recruiting. It is a NA study. The enrollment target is 636 participants. The study started on 2019-07-25. Estimated completion is 2031-10.

What conditions does trial NCT03821129 study?

This clinical trial studies the following conditions: Stroke, PFO - Patent Foramen Ovale. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03821129?

The interventions under investigation include: PFO closure with GORE® CARDIOFORM Septal Occluder (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03821129?

This trial is sponsored by W.L.Gore & Associates, which has 117 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03821129 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial