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NCT03055858 · ClinicalTrials.gov registry record · NA
AMPLATZER Duct Occluder II Additional Sizes
A NA study of Patent Ductus Arteriosus, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 9
- Study locations
NCT03055858: Completed NA study of Patent Ductus Arteriosus, sponsored by Abbott Medical Devices.
NCT03055858 is a NA study of Patent Ductus Arteriosus that has completed, run by Abbott Medical Devices. The registered enrollment target is 200 participants, below the 254-participant average among 7 other Patent Ductus Arteriosus trials with a reported enrollment target (21% lower). The trial reports 9 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03055858, a NA study of Patent Ductus Arteriosus, has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
- 9
- Study locations
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.
Primary Outcome
Major complications are defined as device (ADO II AS) or procedure-related adverse events resulting in any of the following: * death, * life-threatening adverse event, * persistent or significant disability/incapacity, and/or * a major open surgical intervention which is performed by a surgeon under general anesthesia
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 |
What the finished NCT03055858 record still lists
NCT03055858 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 254-participant average among 7 other Patent Ductus Arteriosus trials with a reported enrollment target (21% lower).
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.
NCT03055858 lists 9 locations in 9 states (California, Florida, Michigan).
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.
What interventions are being tested in trial NCT03055858?
The interventions under investigation include: ADO II AS (PDA closure) (DEVICE).
Who is sponsoring clinical trial NCT03055858?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
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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