Patent Ductus Arteriosus (PDA)
Conditions
Keywords
patent ductus arteriosus (PDA)
Brief summary
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.
Interventions
DEVICEDevice closure with AMPLATZER Duct Occluder
Device closure with AMPLATZER Duct Occluder
OTHERObjective Performance Criteria
Compare results of device closure to objective performance criteria
Sponsors
Abbott Medical Devices
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Long term follow up data captured at 5, 6 or 7 years post implant | The number of participants with a residual shunt (efficacy) |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Subjects meeting the inclusion/exclusion criteria of the protocol were included in the original clinical trial.
Participants by arm
| Arm | Count |
|---|---|
| Long Term Follow-up for Subjects Implanted With the Device Subjects enrolled in IDE study subject to Post Market Surveillance | 436 |
| Total | 436 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Data not complete | 1 |
| Overall Study | Death | 2 |
| Overall Study | Excluded due to Hurricane Katrina | 30 |
| Overall Study | Lost to Follow-up | 110 |
| Overall Study | Not consented | 15 |
| Overall Study | Outside f-up window | 26 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Long Term Follow-up for Subjects Implanted With the Device |
|---|---|
| Age, Continuous | 6.14 years STANDARD_DEVIATION 11.14 |
| Region of Enrollment United States | 436 participants |
| Sex: Female, Male Female | 298 Participants |
| Sex: Female, Male Male | 138 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 8 / 436 |
| serious Total, serious adverse events | 1 / 436 |
Outcome results
Primary
Reporting of Late Adverse Events Relating to the Device.
Time frame: Long term follow up for data captured at 5, 6 or 7 years post implant
Population: 152 subjects of the 436 subjects eligible for post market survelliance completed a 5, 6 or 7 year follow-up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Long Term Follow-up for Subjects Implanted With the Device | Reporting of Late Adverse Events Relating to the Device. | 9 participant |
Primary
Reporting of Late Efficacy Issues Regarding Patent Ductus Arteriosis (PDA) Closure
The number of participants with a residual shunt (efficacy)
Time frame: Long term follow up data captured at 5, 6 or 7 years post implant
Population: Of the 152 subjects that completed long term follow-up, 128 subjects underwent Transthoracic echocardiogram (TTE) at their final visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Long Term Follow-up for Subjects Implanted With the Device | Reporting of Late Efficacy Issues Regarding Patent Ductus Arteriosis (PDA) Closure | 0 participants |