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Safety and Efficacy Study of reSept ASD Occluder for Treating Secundum ASD
NCT04591392 · View on ClinicalTrials.gov ↗
Study Summary
Evaluation of the safety and efficacy of the reSept ASD Occluder to treat patients with clinically significant secundum atrial septal defect
Conditions Studied
Interventions
- DEVICE reSept ASD Occluder
Study Locations (20)
California
- Children's Hospital of Los Angeles — Los Angeles
- Los Robles Regional Medical Center — Thousand Oaks
Michigan
- University of Michigan — Ann Arbor
- Children's Hospital of Michigan — Detroit
Ohio
- Cincinnati Children's Hospital — Cincinnati
- Nationwide Children's Hospital — Columbus
Pennsylvania
- Children's Hospital of Philadelphia — Philadelphia
- UPMC Children's Hospital of Pittsburgh — Pittsburgh
Alabama
- University of Alabama at Birmingham — Birmingham
Colorado
- Children's Hospital Colorado — Aurora
Connecticut
- Yale University — New Haven
Florida
- Joe DiMaggio Children's Hospital/Memorial Healthcare System — Hollywood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2021-03-12 |
| Est. Completion | 2032-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04591392
The ClinicalTrials.gov registry entry for NCT04591392 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 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is atHeart Medical, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 7 conditions, with Cardiovascular Diseases appearing as the primary indexed condition, and to 1 intervention — of which reSept ASD 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: NCT04591392 reports 20 study locations spanning 16 distinct geographic areas — top geographies include California, Michigan, Ohio. 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 NCT04591392 about?
NCT04591392 is a clinical study titled "Safety and Efficacy Study of reSept ASD Occluder for Treating Secundum ASD". Evaluation of the safety and efficacy of the reSept ASD Occluder to treat patients with clinically significant secundum atrial septal defect
What is the current status of trial NCT04591392?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 250 participants. The study started on 2021-03-12. Estimated completion is 2032-03.
What conditions does trial NCT04591392 study?
This clinical trial studies the following conditions: Cardiovascular Diseases, Heart Diseases, Heart Defects, Congenital, Cardiovascular Abnormalities, Congenital Abnormalities. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04591392?
The interventions under investigation include: reSept ASD Occluder (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04591392?
This trial is sponsored by atHeart Medical, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04591392 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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