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Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder - Post Approval Study
NCT00647387 · View on ClinicalTrials.gov ↗
Study Summary
The AMPLATZER Muscular VSD Occluder was approved by the US Food and Drug Administration (FDA) in September, 2007. This study is designed to further evaluate the safety and effectiveness in subjects implanted with the AMPLATZER Muscular VSD Occluder.
Conditions Studied
Interventions
- DEVICE Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder)
Study Locations (20)
California
- Children's Hospital Los Angeles (USC) — Los Angeles
- Cedars-Sinai Medical Center — Los Angeles
- Ronald Reagan UCLA Medical Center — Los Angeles
- Valley Children's Hospital — Madera
- Stanford University Medical Center — Palo Alto
- Rady Children's Hospital — San Diego
Florida
- Joe DiMaggio Children's Hospital — Hollywood
- Jackson Memorial Hospital — Miami
- Arnold Palmer Hospital — Orlando
- All Children's Hospital — St. Petersburg
Arizona
- St. Joseph Hospital and Medical Center — Phoenix
- Phoenix Children's Hospital — Phoenix
Georgia
- Children's Healthcare of Atlanta — Atlanta
- Augusta University — Augusta
Illinois
- University of Chicago Medical Center — Chicago
- Advocate Christ Medical Center — Oak Lawn
Colorado
- Children's Hospital of Colorado — Aurora
Connecticut
- Yale New Haven Hospital — New Haven
Delaware
- Nemours/Alfred I. duPont Hospital for Children — Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2008-03 |
| Est. Completion | 2024-02-23 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00647387
The ClinicalTrials.gov registry entry for NCT00647387 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 92 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 Ventricular Septal Defects appearing as the primary indexed condition, and to 1 intervention — of which Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD 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: NCT00647387 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Florida, Arizona. 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 NCT00647387 about?
NCT00647387 is a clinical study titled "Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder - Post Approval Study". The AMPLATZER Muscular VSD Occluder was approved by the US Food and Drug Administration (FDA) in September, 2007. This study is designed to further evaluate the safety and effectiveness in subjects implanted with the AMPLATZER Muscular VSD Occluder.
What is the current status of trial NCT00647387?
This trial is currently completed. It is a NA study. The enrollment target is 92 participants. The study started on 2008-03. Estimated completion is 2024-02-23.
What conditions does trial NCT00647387 study?
This clinical trial studies the following conditions: Ventricular Septal Defects. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00647387?
The interventions under investigation include: Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00647387?
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 NCT00647387 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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