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| ID | Type | Description | Link |
|---|---|---|---|
| G980103 |
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AGA-004 - The objective of the study is to determine safety, effectiveness and clinical utility of the AMPLATZER Duct Occluder in patients with patent ductus arteriosus. AGA-007 - The objective of this study is to evaluate the long term safety and effectiveness issues that may not have have been adequately addressed during AGA-004.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| implant to close PDA | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device closure with AMPLATZER Duct Occluder | Device | Device closure with AMPLATZER Duct Occluder |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reporting of Late Adverse Events Relating to the Device. | Long term follow up for data captured at 5, 6 or 7 years post implant | |
| Reporting of Late Efficacy Issues Regarding Patent Ductus Arteriosis (PDA) Closure | The number of participants with a residual shunt (efficacy) | Long term follow up data captured at 5, 6 or 7 years post implant |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | United States | ||
| Children's Hospital |
Subjects meeting the inclusion/exclusion criteria of the protocol were included in the original clinical trial.
Subjects were recruited in medical clinics. The first subject enrolled was September 10, 1999. The last follow-up occurred in the Post Market Surveillance Study on August 29, 2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Long Term Follow-up for Subjects Implanted With the Device | Subjects enrolled in IDE study subject to Post Market Surveillance |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Objective Performance Criteria | Other | Compare results of device closure to objective performance criteria |
|
| San Diego |
| California |
| 92123 |
| United States |
| Children's Hospital | Denver | Colorado | 80218 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| Arnold Palmer Hospital | Orlando | Florida | 32806 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | United States |
| Louisana State University Medical Center | New Orleans | Louisiana | 70112 | United States |
| New England Medical Center | Boston | Massachusetts | 02111 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Washington University Medical Center | St Louis | Missouri | 63110 | United States |
| Children's Hospital UN/CU) | Omaha | Nebraska | 68114 | United States |
| Columbia University | New York | New York | 10032 | United States |
| Childrens Hospital | Rochester | New York | 14642 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| University of Texas | Dallas | Texas | 75235 | United States |
| Cook Children's Heart Center | Fort Worth | Texas | 76104 | United States |
| Children's Hospital of the King's Daughters | Norfolk | Virginia | 30322 | United States |
| University of Washington Medical Center | Seattle | Washington | 98195 | United States |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53201 | United States |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Long Term Follow-up for Subjects Implanted With the Device | Subjects enrolled in IDE study subject to Post Market Surveillance |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Reporting of Late Adverse Events Relating to the Device. | 152 subjects of the 436 subjects eligible for post market survelliance completed a 5, 6 or 7 year follow-up. | Posted | Number | participant | Long term follow up for data captured at 5, 6 or 7 years post implant |
|
|
| |||||||||||||||||||||||||||
| Primary | Reporting of Late Efficacy Issues Regarding Patent Ductus Arteriosis (PDA) Closure | The number of participants with a residual shunt (efficacy) | Of the 152 subjects that completed long term follow-up, 128 subjects underwent Transthoracic echocardiogram (TTE) at their final visit. | Posted | Number | participants | Long term follow up data captured at 5, 6 or 7 years post implant |
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|
Adverse event data was collected during routine follow-up visits or if an event occurred between visits.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Long Term Follow-up for Subjects Implanted With the Device | Subjects enrolled in IDE study subject to Post Market Surveillance | 1 | 436 | 8 | 436 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Obstruction of Pulmonary Artery with Gradient | Cardiac disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mitral Valve regurgitation | Cardiac disorders |
| |||
| Left Pulmonary artery stenosis | Cardiac disorders |
| |||
| Aortic Stenosis with Chest Pain | Cardiac disorders |
| |||
| Death | General disorders |
| |||
| Atrial ectopic beats | Cardiac disorders |
| |||
| Echo finding | Cardiac disorders |
| |||
| Bronchitis | Respiratory, thoracic and mediastinal disorders |
| |||
| Diabetic ketoacidosis | Endocrine disorders |
| |||
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Mifek | St. Jude Medical Formally AGA Medical Corporation | 6517565586 | jmifek@sjm.com |
| ID | Term |
|---|---|
| D004374 | Ductus Arteriosus, Patent |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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