Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03821129 · ClinicalTrials.gov registry record · 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
A NA study of Stroke and PFO - Patent Foramen Ovale, sponsored by W.L.Gore & Associates.
- Recruiting
- Registry status
- NA
- Development phase
- 636
- Enrollment target
- 20
- Study locations
NCT03821129: Recruiting NA study of Stroke and PFO - Patent Foramen Ovale, sponsored by W.L.Gore & Associates.
NCT03821129 is a NA study of Stroke and PFO - Patent Foramen Ovale that is actively recruiting participants, run by W.L.Gore & Associates. The registered enrollment target is 636 participants, below the 12,015-participant average among 454 other Stroke trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03821129, a NA study of Stroke and PFO - Patent Foramen Ovale, is actively recruiting participants, sponsored by W.L.Gore & Associates.
- RECRUITING
- Registry status
- NA
- Development phase
- 636 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Proportion of subjects with recurrent ischemic stroke post study device implant
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 636 participants |
| Start Date | 2019-07-25 |
| Est. Completion | 2031-10 |
| Phase | NA |
What NCT03821129 shows while recruiting
NCT03821129 is an interventional study that assigns participants to a tested intervention. The registered 636 participants enrollment target is mid-sized for trials with a published cap, below the 12,015-participant average among 454 other Stroke trials with a reported enrollment target (95% lower).
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.
NCT03821129 names 20 study sites across 10 states, led by California, Florida, Illinois.
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.
What interventions are being tested in trial NCT03821129?
The interventions under investigation include: PFO closure with GORE® CARDIOFORM Septal Occluder (DEVICE).
Who is sponsoring clinical trial NCT03821129?
This trial is sponsored by W.L.Gore & Associates, which has 53 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Stroke
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03821129's enrollment target sits among peer trials
636 48th of 454 higher than 407 of 454 other Stroke trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stroke trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Tracking a Tactile Signal Along the Nervous System
RECRUITING · NA
-
Transcranial Direct Current Stimulation (tDCS) With Verb Network Strengthening Treatment (VNeST) in Chronic Aphasia
RECRUITING · NA
-
Strategy Training for Individuals With Unilateral Neglect
RECRUITING · NA
-
Weight Loss and ExeRcise
RECRUITING · NA
-
Safety and Feasibility of an ExoNET for Supination Assistance for Stroke Survivors
RECRUITING · NA
-
Deep Brain Stimulation Motor Ventral Thalamus (VOP/VIM) for Restoration of Speech and Upper-limb Function in People With Subcortical Stroke
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03478826 · 635 participants
Creation of a Biospecimen Repository From Patients With Interstitial Lung Diseases (ILD)
- NCT00573027 · 634 participants · NA
Heart Disease of the Small Arteries in Women and Men
- NCT04108156 · 634 participants · Phase 3
A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Substudy to Evaluate the Safety of Re-implanting the PDS With Ranibizumab in Participants With DME
- NCT07237295 · 634 participants · NA
CommunityRx-Kidney Health
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI