ποΈ Verified NIH Record β’ Updated 2026-03-09
AMPLATZER PFO Occluder Post Approval Study (NCT03309332)
OSB Lead-AMPLATZER PFO Occluder New Enrollment PAS
π΅ Active, Not Recruiting Observational / Diagnostic βοΈ Medical Device Protocol Sponsor: Abbott Medical Devices
π©Ί Plain-English Summary (8th-Grade Level)
The purpose of this single arm, multi-center study is to confirm the safety and effectiveness of the AMPLATZERβ’ PFO Occluder in the post Approval Setting.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham β Birmingham, Alabama
Age range: 18 Years to 60 Years
π§ͺ Interventions in This Study
π "Do I Qualify?" β 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria β
π All Participating Trial Locations (88 Sites)
Showing the first 25 of 88 sites.
- University of Alabama at Birmingham β Birmingham, Alabama
- Heart Center Research, LLC β Huntsville, Alabama
- Chandler Regional Medical Center β Chandler, Arizona
- St. Joseph's Hospital and Medical Center β Phoenix, Arizona
- Scottsdale Healthcare Shea β Scottsdale, Arizona
- Pima Heart Physicians, PC β Tucson, Arizona
- UAMS Medical Center β Little Rock, Arkansas
- Kaiser Permanente Los Angeles Medical Center β Los Angeles, California
- USC University Hospital β Los Angeles, California
- Ronald Reagan UCLA Medical Center β Los Angeles, California
- Sutter Medical Center β Sacramento, California
- San Diego Cardiac Center β San Diego, California
- University of California at San Francisco β San Francisco, California
- Stanford University Medical Center β Stanford, California
- Los Robles Hospital and Medical Center β Thousand Oaks, California
- University of Colorado Hospital β Aurora, Colorado
- Memorial Hospital of Colorado Springs β Colorado Springs, Colorado
- Denver Heart β Denver, Colorado
- South Denver Cardiology Associates PC β Littleton, Colorado
- MedStar Washington Hospital Center β Washington D.C., District of Columbia
- St. Vincent's Medical Center β Jacksonville, Florida
- Baptist Medical Center β Jacksonville, Florida
- First Coast Cardiovascular Institute β Jacksonville, Florida
- Orlando Health β Orlando, Florida
- Cleveland Clinic Florida β Weston, Florida
π° Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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π‘ How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.