๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2025-05-05

Safety and Efficacy Study of reSept ASD Occluder for Treating Secundum ASD (NCT04591392)

Evaluation of the Safety and Efficacy of the reSept ASD Occluder to Treat Patients With Clinically Significant Secundum Atrial Septal Defect

๐Ÿ”ต Active, Not Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: atHeart Medical

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

Evaluation of the safety and efficacy of the reSept ASD Occluder to treat patients with clinically significant secundum atrial septal defect

Who can join: Review the eligibility criteria below.

Location: University of Alabama at Birmingham โ€” Birmingham, Alabama

Age range: Not specified to 84 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (32 Sites)

Showing the first 25 of 32 sites.

  • University of Alabama at Birmingham โ€” Birmingham, Alabama
  • Children's Hospital of Los Angeles โ€” Los Angeles, California
  • Los Robles Regional Medical Center โ€” Thousand Oaks, California
  • Children's Hospital Colorado โ€” Aurora, Colorado
  • Yale University โ€” New Haven, Connecticut
  • Joe DiMaggio Children's Hospital/Memorial Healthcare System โ€” Hollywood, Florida
  • Children's Healthcare of Atlanta โ€” Atlanta, Georgia
  • Advocate Children's Hospital โ€” Oak Lawn, Illinois
  • Riley Hospital for Children โ€” Indianapolis, Indiana
  • Boston Children's Hospital โ€” Boston, Massachusetts
  • University of Michigan โ€” Ann Arbor, Michigan
  • Children's Hospital of Michigan โ€” Detroit, Michigan
  • Washington University School of Medicine โ€” St Louis, Missouri
  • Mount Sinai Medical Center โ€” New York, New York
  • Cincinnati Children's Hospital โ€” Cincinnati, Ohio
  • Nationwide Children's Hospital โ€” Columbus, Ohio
  • Children's Hospital of Philadelphia โ€” Philadelphia, Pennsylvania
  • UPMC Children's Hospital of Pittsburgh โ€” Pittsburgh, Pennsylvania
  • Medical University of South Carolina โ€” Charleston, South Carolina
  • Medical City Dallas Hospital โ€” Dallas, Texas
  • Texas Children's Hospital โ€” Houston, Texas
  • Primary Children's Hospital โ€” Salt Lake City, Utah
  • University of Virginia โ€” Charlottesville, Virginia
  • Seattle Children's Hospital โ€” Seattle, Washington
  • Toronto General Hospital โ€” Toronto,

๐Ÿ’ฐ 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 ยง 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.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—