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AMPLATZER PFO Occluder Post Approval Study
NCT03309332 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this single arm, multi-center study is to confirm the safety and effectiveness of the AMPLATZER™ PFO Occluder in the post Approval Setting.
Conditions Studied
Interventions
- DEVICE AMPLATZER™ PFO Occluder
Study Locations (20)
California
- Kaiser Permanente Los Angeles Medical Center — Los Angeles
- USC University Hospital — Los Angeles
- Ronald Reagan UCLA Medical Center — Los Angeles
- Sutter Medical Center — Sacramento
- San Diego Cardiac Center — San Diego
- University of California at San Francisco — San Francisco
- Stanford University Medical Center — Stanford
- Los Robles Hospital and Medical Center — Thousand Oaks
Arizona
- Chandler Regional Medical Center — Chandler
- St. Joseph's Hospital and Medical Center — Phoenix
- Scottsdale Healthcare Shea — Scottsdale
- Pima Heart Physicians, PC — Tucson
Colorado
- University of Colorado Hospital — Aurora
- Memorial Hospital of Colorado Springs — Colorado Springs
- Denver Heart — Denver
- South Denver Cardiology Associates PC — Littleton
Alabama
- University of Alabama at Birmingham — Birmingham
- Heart Center Research, LLC — Huntsville
Arkansas
- UAMS Medical Center — Little Rock
District of Columbia
- MedStar Washington Hospital Center — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,214 participants |
| Start Date | 2018-01-31 |
| Est. Completion | 2030-02-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03309332
The ClinicalTrials.gov registry entry for NCT03309332 describes a study currently listed as active not 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 1,214 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott Medical Devices, which has 155 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 AMPLATZER™ PFO 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: NCT03309332 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Arizona, Colorado. 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 NCT03309332 about?
NCT03309332 is a clinical study titled "AMPLATZER PFO Occluder Post Approval Study". The purpose of this single arm, multi-center study is to confirm the safety and effectiveness of the AMPLATZER™ PFO Occluder in the post Approval Setting.
What is the current status of trial NCT03309332?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 1,214 participants. The study started on 2018-01-31. Estimated completion is 2030-02-05.
What conditions does trial NCT03309332 study?
This clinical trial studies the following conditions: Stroke, 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 NCT03309332?
The interventions under investigation include: AMPLATZER™ PFO Occluder (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03309332?
This trial is sponsored by Abbott Medical Devices, which has 155 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03309332 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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