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AMPLATZER Duct Occluder II Additional Sizes
NCT03055858 · View on ClinicalTrials.gov ↗
Study Summary
The ADO II AS Study is a single arm, prospective, multicenter, nonrandomized clinical investigation to characterize the safety and effectiveness of the ADO II AS device in patients with a patent ductus arteriosus (PDA). Subjects will be implanted with the ADO II AS device using a transcatheter femoral vessel approach under fluoroscopic and echocardiographic guidance. To account for subject dropout, up to 50 subjects will be enrolled in this clinical investigation. Up to an additional 150 subjects may be enrolled under continued access. The clinical investigation will be conducted at up to 10 centers in the United States. Subjects participating in this clinical investigation will be followed for 3 years. The expected duration of enrollment is 18 months. The total duration of the clinical investigation is expected to be 4.5 years.
Conditions Studied
Interventions
- DEVICE ADO II AS (PDA closure)
Study Locations (9)
California
- Cedars Sinai Medical Center — Los Angeles
Florida
- Arnold Palmer Hospital — Orlando
Michigan
- Children's Hospital of Michigan — Detroit
Missouri
- St. Louis Children's Hospital — St Louis
Ohio
- Nationwide Children's Hospital — Columbus
Pennsylvania
- Children's Hospital of Philadelphia — Philadelphia
Tennessee
- Methodist LeBonheur Healthcare — Memphis
Texas
- Texas Children's Hospital — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2017-06-05 |
| Est. Completion | 2022-04-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03055858
The ClinicalTrials.gov registry entry for NCT03055858 describes a study currently listed as completed. 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 200 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 1 condition, with Patent Ductus Arteriosus appearing as the primary indexed condition, and to 1 intervention — of which ADO II AS (PDA closure) 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: NCT03055858 reports 9 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, Michigan. 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 NCT03055858 about?
NCT03055858 is a clinical study titled "AMPLATZER Duct Occluder II Additional Sizes". The ADO II AS Study is a single arm, prospective, multicenter, nonrandomized clinical investigation to characterize the safety and effectiveness of the ADO II AS device in patients with a patent ductus arteriosus (PDA). Subjects will be implanted with the ADO II AS device using a transcatheter femor...
What is the current status of trial NCT03055858?
This trial is currently completed. It is a NA study. The enrollment target is 200 participants. The study started on 2017-06-05. Estimated completion is 2022-04-05.
What conditions does trial NCT03055858 study?
This clinical trial studies the following conditions: Patent Ductus Arteriosus. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03055858?
The interventions under investigation include: ADO II AS (PDA closure) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03055858?
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 NCT03055858 being conducted?
This trial has 9 study locations across California, Florida, Michigan, Missouri, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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