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NCT00647387 · ClinicalTrials.gov registry record · NA
Closure of Muscular Ventricular Septal Defects (VSDs) With the AMPLATZER Muscular VSD (MuVSD) Occluder - Post Approval Study
A NA study of Ventricular Septal Defects, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- NA
- Development phase
- 92
- Enrollment target
- 20
- Study locations
NCT00647387: Completed NA study of Ventricular Septal Defects, sponsored by Abbott Medical Devices.
NCT00647387 is a NA study of Ventricular Septal Defects that has completed, run by Abbott Medical Devices. The registered enrollment target is 92 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00647387, a NA study of Ventricular Septal Defects, has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- NA
- Development phase
- 92 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Technical success was defined as successful deployment of the device (Amplatzer™ Muscular VSD Occluder) in subjects with the ventricular septal defect (VSD).
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 |
What the finished NCT00647387 record still lists
NCT00647387 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
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.
NCT00647387 names 20 study sites across 9 states, led by California, Florida, Arizona.
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.
What interventions are being tested in trial NCT00647387?
The interventions under investigation include: Muscular VSD Occluder device implantation (AMPLATZER Muscular VSD Occluder) (DEVICE).
Who is sponsoring clinical trial NCT00647387?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00647387's enrollment target sits among peer trials
92 937th of 2000 higher than 1,062 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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