Closure Of Patent Ductus Arteriosus With the AMPLATZER Duct Occluder the AMPLATZER® Duct Occluder
This study has been completed.
Sponsor:
AGA Medical Corporation
Information provided by:
AGA Medical Corporation
ClinicalTrials.gov Identifier:
NCT00583596
First received: December 20, 2007
Last updated: January 31, 2010
Last verified: January 2010
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Purpose
The objective of the study is to determine safety, effectiveness and clinical utility of the AMPLATZER Duct Occluder in patients with patent ductus arteriosus.
| Condition | Intervention |
|---|---|
|
Patent Ductus Arteriosus PDA |
Device: Device closure with AMPLATZER Duct Occluder Other: Objective Performance Criteria |
AGA Medical Corporation has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Further study details as provided by AGA Medical Corporation:
Primary Outcome Measures:
- The rate of serious and major adverse events will be ≤ 6%. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- The residual patency rate is expected to be < 15% by Doppler color flow mapping and <5% by clinical exam. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Enrollment: | 441 |
| Study Start Date: | October 1999 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Device: Device closure with AMPLATZER Duct Occluder
Device closure with AMPLATZER Duct Occluder
|
| 2 |
Other: Objective Performance Criteria
Compare results of device closure to objective performance criteria
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with a demonstrated patent ductus arteriosus
- Body weight > 5 Kilograms
Exclusion Criteria:
- Pulmonary vascular resistance above 8 Woods units or a Rp/Rs >0.4.
- Additional cardiac or non-cardiac abnormality that can reasonably be expected to significantly affect the patient's health adversely in the next two years, i.e.: cancer, Eisenmenger's syndrome, other serious congenital heart disease.
- Pelvic vein or inferior vena cava thrombosis
- Sepsis (local/generalized) or any type of infection that cannot be successfully treated prior to device placement.
- History of repeated pulmonary infection
- Demonstrated intracardiac thrombi on echocardiography • Inability to obtain informed consent
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00583596
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| United States, Alabama | |
| University of Alabama | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Children's Hospital | |
| San Diego, California, United States, 92123 | |
| United States, Colorado | |
| Children's Hospital | |
| Denver, Colorado, United States, 80218 | |
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| University of Florida | |
| Gainesville, Florida, United States, 32610 | |
| Arnold Palmer Hospital | |
| Orlando, Florida, United States, 32806 | |
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| United States, Indiana | |
| Indiana University School of Medicine | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Louisiana | |
| Louisana State University Medical Center | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Massachusetts | |
| New England Medical Center | |
| Boston, Massachusetts, United States, 02111 | |
| United States, Minnesota | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States, 39216 | |
| United States, Missouri | |
| Washington University Medical Center | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| Children's Hospital UN/CU) | |
| Omaha, Nebraska, United States, 68114 | |
| United States, New York | |
| Columbia University | |
| New York, New York, United States, 10032 | |
| Childrens Hospital | |
| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| University of North Carolina | |
| Chapel Hill, North Carolina, United States, 27599 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Texas | |
| University of Texas | |
| Dallas, Texas, United States, 75235 | |
| Cook Children's Heart Center | |
| Fort Worth, Texas, United States, 76104 | |
| United States, Virginia | |
| Children's Hospital of the King's Daughters | |
| Norfolk, Virginia, United States, 30322 | |
| United States, Washington | |
| University of Washington Medical Center | |
| Seattle, Washington, United States, 98195 | |
| United States, Wisconsin | |
| Children's Hospital of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53201 | |
Sponsors and Collaborators
AGA Medical Corporation
More Information
Additional Information:
No publications provided
| Responsible Party: | Tammy Benson, AGA Medical Corporation |
| ClinicalTrials.gov Identifier: | NCT00583596 History of Changes |
| Other Study ID Numbers: | AGA-004, G980103 |
| Study First Received: | December 20, 2007 |
| Last Updated: | January 31, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AGA Medical Corporation:
|
patent ductus arteriosus PDA |
Additional relevant MeSH terms:
|
Ductus Arteriosus, Patent Heart Defects, Congenital Cardiovascular Abnormalities |
Cardiovascular Diseases Heart Diseases Congenital Abnormalities |
ClinicalTrials.gov processed this record on May 23, 2013