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NCT00650936 · ClinicalTrials.gov registry record · NA
Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study
A NA study of Atrial Septal Defect, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- NA
- Development phase
- 1,000
- Enrollment target
- 20
- Study locations
NCT00650936: Completed NA study of Atrial Septal Defect, sponsored by Abbott Medical Devices.
NCT00650936 is a NA study of Atrial Septal Defect that has completed, run by Abbott Medical Devices. The registered enrollment target is 1,000 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (29% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00650936, a NA study of Atrial Septal Defect, has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,000 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to prospectively evaluate the incidence of hemodynamic compromise and to obtain long-term survival data on patients with the AMPLATZER Septal Occluder
Primary Outcome
The primary efficacy endpoint was the two-year incidence rate of device-related hemodynamic compromise.
Conditions Studied
Interventions
- DEVICE AMPLATZER Septal Occluder
Study Locations (20)
Florida
- Joe DiMaggio Children's Hospital - Hollywood
- Jacksonville Pediatric Cardiovascular Center - Jacksonville
- Miami Children's Hospital - Miami
- Arnold Palmer Hospital for Children - Orlando
- Tampa General Hospital - Tampa
California
- Kaiser Permanente - Los Angeles
- Children's Hospital of Central California - Madera
- Children's Hospital Oakland - Oakland
- University of California, San Francisco - San Francisco
Colorado
- Aurora Denver Cardiology Associates - Aurora
- Medical Center of the Rockies - Loveland
District of Columbia
- Children's National Medical Center - Washington D.C.
- Washington Hospital Center - Washington D.C.
Illinois
- Rush University Medical Center - Chicago
- Hope Children's Hospital - Oak Lawn
Indiana
- Indiana University - Indianapolis
- Riley Hospital for Children - Indianapolis
Alabama
- University of Alabama at Birmingham - Birmingham
Georgia
- Children's Healthcare of Atlanta - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2007-08 |
| Est. Completion | 2014-06 |
| Phase | NA |
What the finished NCT00650936 record still lists
NCT00650936 is an interventional study that assigns participants to a tested intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (29% lower).
The record links to 1 condition, with Atrial Septal Defect appearing as the primary indexed condition, and to 1 intervention - of which AMPLATZER Septal Occluder is the first listed.
NCT00650936 names 20 study sites across 9 states, led by Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT00650936 about?
NCT00650936 is a clinical study titled "Closure of Atrial Septal Defects With the AMPLATZER Septal Occluder - Post Approval Study". The purpose of this study is to prospectively evaluate the incidence of hemodynamic compromise and to obtain long-term survival data on patients with the AMPLATZER Septal Occluder
What is the current status of trial NCT00650936?
This trial is currently completed. It is a NA study. The enrollment target is 1,000 participants. The study started on 2007-08. Estimated completion is 2014-06.
What conditions does trial NCT00650936 study?
This clinical trial studies the following conditions: Atrial Septal Defect.
What interventions are being tested in trial NCT00650936?
The interventions under investigation include: AMPLATZER Septal Occluder (DEVICE).
Who is sponsoring clinical trial NCT00650936?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00650936 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00650936's enrollment target sits among peer trials
1,000 107th of 2000 higher than 1,880 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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