Patent Ductus Arteriosus
Conditions
Keywords
patent ductus arteriosus, PDA
Brief summary
The objective of this study is to investigate the safety and effectiveness of the ADO II in patients with a PDA.
Interventions
DEVICEAMPLATZER Duct Occluder II
AMPLATZER Duct Occluder II
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* Subject must have diagnosis of a PDA * Subject must have a PDA \< 5.5mm in diameter by angiography * Subject must have a PDA \< 12mm in length by angiography * Subject must have a PDA \> 3mm in length by angiography * Subject/legally authorized representative must give consent to participate in the clinical study * Subject/legally authorized representative must consent to follow-up for the duration of the clinical study
Exclusion criteria
* Subject must not be \< 6 kilograms for the procedure * Subject must not be \< 6 months of age * Subject must not be ≥ 18 years of age * Subject must not have a descending aorta \< 10mm in diameter * Subject must not have a right to left shunt through the patent ductus arteriosus * Subject must not have PVR above 8 Woods units or a Rp/Rs \>0.4 * Subject must not have intracardiac thrombus * Subject must not have additional cardiac anomalies requiring surgical or interventional correction * Subject must not have history of more than two lower respiratory infections within the last year (i.e., pneumonia) * Subject must not have active infection requiring treatment at the time of implant * Subject must not have contraindication to anticoagulation treatment * Female subjects of child bearing age must not be pregnant or desire to become pregnant within six months post implant\* * Subject must not be participating in another study for an investigational drug and/or device that may clinically interfere with this study's endpoints * If the subject desires to become pregnant after six months post-implant, further restriction is at the discretion of their physician.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Safety Endpoint is the Rate of Device and Procedure Related Serious Adverse Events (SAE) 180 Days Post Procedure. | 180 days | The primary safety endpoint is the rate of device and/or procedure related SAEs reported in subjects whom device placement is attempted from the procedure through 180 days post procedure SAEs are defined as: Adverse events resulting in the following; death, life-threatening adverse event, inpatient hospitalization or prolongation of existing hospital stay, persistent or significant disability/incapacity or medically significant event. |
| The Primary Effectiveness Endpoint is the Rate of Complete Closure of the Ductus Arteriosus at the Six-month Follow-up. | 180 days | The primary efficacy endpoint is the rate of complete closure of the ductus arteriosus as assessed by the absence of residual flow and continuous murmur at the six-month follow-up by transthoracic echocardiography and physical exam respectively. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Device AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II | 192 |
| Total | 192 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Device |
|---|---|
| Age, Categorical <=18 years | 192 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 4.4 years STANDARD_DEVIATION 4.2 |
| Region of Enrollment United States | 192 participants |
| Sex: Female, Male Female | 120 Participants |
| Sex: Female, Male Male | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 19 / 192 |
| serious Total, serious adverse events | 3 / 192 |
Outcome results
Primary
The Primary Effectiveness Endpoint is the Rate of Complete Closure of the Ductus Arteriosus at the Six-month Follow-up.
The primary efficacy endpoint is the rate of complete closure of the ductus arteriosus as assessed by the absence of residual flow and continuous murmur at the six-month follow-up by transthoracic echocardiography and physical exam respectively.
Time frame: 180 days
Population: Of the 192 enrolled, 178 subjects experienced successful device placement.Of the 178 subjects with the device implanted,166 had a 6-month TTE and physical examination before 200 days post procedure or had an explant before the 6-month follow-up interval ended.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Device | The Primary Effectiveness Endpoint is the Rate of Complete Closure of the Ductus Arteriosus at the Six-month Follow-up. | 98.19 percentage of participants |
Primary
The Primary Safety Endpoint is the Rate of Device and Procedure Related Serious Adverse Events (SAE) 180 Days Post Procedure.
The primary safety endpoint is the rate of device and/or procedure related SAEs reported in subjects whom device placement is attempted from the procedure through 180 days post procedure SAEs are defined as: Adverse events resulting in the following; death, life-threatening adverse event, inpatient hospitalization or prolongation of existing hospital stay, persistent or significant disability/incapacity or medically significant event.
Time frame: 180 days
Population: Of the 192 enrolled subjects, 188 completed follow-up through 180 days post procedure;3 subjects were lost to follow-up (LTFU) before the 180-day interval and 1 subject was discontinued at the end of the 6-month visit without follow-up.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Device | The Primary Safety Endpoint is the Rate of Device and Procedure Related Serious Adverse Events (SAE) 180 Days Post Procedure. | 1.6 percentage of participants |