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 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.
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.
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 |
Interested in This 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, categorized as NA. The registered enrollment target is 636 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,015-participant average among 454 other Stroke trials with a reported enrollment target (95% lower). The listed sponsor is W.L.Gore & Associates, which has 53 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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.
-
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
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.