Patent Ductus Arteriosus
Conditions
Keywords
PDA, SJM-CIP-10171, ADO II AS, IDE, CAP
Brief summary
The ADO II AS Study is a single arm, prospective, multicenter, nonrandomized clinical investigation to characterize the safety and effectiveness of the ADO II AS device in patients with a patent ductus arteriosus (PDA). Subjects will be implanted with the ADO II AS device using a transcatheter femoral vessel approach under fluoroscopic and echocardiographic guidance. To account for subject dropout, up to 50 subjects will be enrolled in this clinical investigation. Up to an additional 150 subjects may be enrolled under continued access. The clinical investigation will be conducted at up to 10 centers in the United States. Subjects participating in this clinical investigation will be followed for 3 years. The expected duration of enrollment is 18 months. The total duration of the clinical investigation is expected to be 4.5 years.
Interventions
DEVICEADO II AS (PDA closure)
Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).
Sponsors
Abbott Medical Devices
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
ADO II AS device
Eligibility
Sex/Gender
ALL
Age
3 Days to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of a PDA * PDA ≤ 4mm in diameter * PDA ≥ 3mm in length * Subject (or legally authorized representative) is willing to comply with all pre-procedure, post-procedure, and follow-up testing requirements and provides consent to participate in the clinical study NOTE: This study is enrolling children and all local laws and governing IRB requirements will be followed for obtaining informed consent
Exclusion criteria
* Weight \< 700 grams at time of the procedure * Age \< 3 days at time of procedure * Coarctation of the aorta * Left pulmonary artery stenosis * Cardiac output that is dependent on right to left shunt through the patent ductus arteriosus due to pulmonary hypertension * Intracardiac thrombus * Active infection requiring treatment at the time of implant * Female subjects of child bearing potential are either pregnant or desire to become pregnant within six months post implant * Other disease process likely to limit survival to less than six (6) months * Participating in another study for an investigational drug and/or device that may clinically interfere with this study's endpoints
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Endpoint: The Rate of Major Complications After an Attempted ADO II AS Device Implant | Through 180 days | Major complications are defined as device (ADO II AS) or procedure-related adverse events resulting in any of the following: * death, * life-threatening adverse event, * persistent or significant disability/incapacity, and/or * a major open surgical intervention which is performed by a surgeon under general anesthesia |
| Effectiveness Endpoint: The Rate of Effective Closure of the Ductus Arteriosus Among Subjects With a Successful ADO II AS Implant | At the 6-month follow-up | The primary effectiveness endpoint is the rate of effective closure of the ductus arteriosus among subjects with a successful ADO II AS implant as assessed by the presence of either a Grade 0 (none) or Grade 1 (trivial) shunt at the 6-month follow-up by transthoracic echocardiography (TTE). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Rate of Significant Obstruction of the Pulmonary Artery or Aorta | Through 6 month follow-up visit | The rate of significant obstruction of the pulmonary artery or aorta through the 6-month follow-up visit per the following definitions: 1. Significant obstruction of the left pulmonary artery is defined as less than 30% flow to the left lung by lung perfusion scan or a peak instantaneous gradient in left pulmonary artery ≥35 mmHg by echocardiogram if lung perfusion scan is not available. OR 2. Significant obstruction of the aorta is defined as a gradient of ≥20 mmHg in the aortic isthmus by invasive aortic catheterization or a mean gradient ≥20 mmHg in the aortic isthmus by echocardiogram if invasive aortic catheterization is not available. |
Countries
United States
Participant flow
Recruitment details
A total of 50 subjects were enrolled in the ADO II AS IDE study at 8 centers in the United States between 5 June 2017 and 25 January 2018. Following completion of enrollment in the IDE cohort, an additional 150 subjects were enrolled in the continued access protocol (CAP) between 26 March 2018 and 1 February 2019.
Participants by arm
| Arm | Count |
|---|---|
| PDA Closure ADO II AS (PDA closure): Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS). | 200 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 9 |
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Missed Follow-Up Visits | 18 |
| Overall Study | Withdrawal by Subject | 11 |
Baseline characteristics
| Characteristic | PDA Closure |
|---|---|
| Age, Continuous CAP Cohort | 13.10 months STANDARD_DEVIATION 34.23 |
| Age, Continuous IDE Cohort | 16.37 months STANDARD_DEVIATION 32.45 |
| Ethnicity (NIH/OMB) CAP Cohort Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) CAP Cohort Not Hispanic or Latino | 129 Participants |
| Ethnicity (NIH/OMB) CAP Cohort Unknown or Not Reported | 5 Participants |
| Ethnicity (NIH/OMB) IDE Cohort Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) IDE Cohort Not Hispanic or Latino | 44 Participants |
| Ethnicity (NIH/OMB) IDE Cohort Unknown or Not Reported | 5 Participants |
| PDA Length CAP | 9.51 mm STANDARD_DEVIATION 2.98 |
| PDA Length IDE | 8.28 mm STANDARD_DEVIATION 2.7 |
| Race (NIH/OMB) CAP Cohort American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) CAP Cohort Asian | 10 Participants |
| Race (NIH/OMB) CAP Cohort Black or African American | 55 Participants |
| Race (NIH/OMB) CAP Cohort More than one race | 5 Participants |
| Race (NIH/OMB) CAP Cohort Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) CAP Cohort Unknown or Not Reported | 21 Participants |
| Race (NIH/OMB) CAP Cohort White | 57 Participants |
| Race (NIH/OMB) IDE Cohort American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) IDE Cohort Asian | 0 Participants |
| Race (NIH/OMB) IDE Cohort Black or African American | 21 Participants |
| Race (NIH/OMB) IDE Cohort More than one race | 0 Participants |
| Race (NIH/OMB) IDE Cohort Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) IDE Cohort Unknown or Not Reported | 8 Participants |
| Race (NIH/OMB) IDE Cohort White | 21 Participants |
| Region of Enrollment United States | 200 participants |
| Sex: Female, Male CAP Cohort Female | 69 Participants |
| Sex: Female, Male CAP Cohort Male | 81 Participants |
| Sex: Female, Male IDE Cohort Female | 29 Participants |
| Sex: Female, Male IDE Cohort Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 9 / 200 |
| other Total, other adverse events | 26 / 200 |
| serious Total, serious adverse events | 13 / 200 |
Outcome results
Primary
Effectiveness Endpoint: The Rate of Effective Closure of the Ductus Arteriosus Among Subjects With a Successful ADO II AS Implant
The primary effectiveness endpoint is the rate of effective closure of the ductus arteriosus among subjects with a successful ADO II AS implant as assessed by the presence of either a Grade 0 (none) or Grade 1 (trivial) shunt at the 6-month follow-up by transthoracic echocardiography (TTE).
Time frame: At the 6-month follow-up
Population: The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150). The analysis population included the subjects who were available at the time of evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PDA Closure | Effectiveness Endpoint: The Rate of Effective Closure of the Ductus Arteriosus Among Subjects With a Successful ADO II AS Implant | IDE Cohort | 100 percentage of participants |
| PDA Closure | Effectiveness Endpoint: The Rate of Effective Closure of the Ductus Arteriosus Among Subjects With a Successful ADO II AS Implant | CAP Cohort | 99.2 percentage of participants |
Primary
Safety Endpoint: The Rate of Major Complications After an Attempted ADO II AS Device Implant
Major complications are defined as device (ADO II AS) or procedure-related adverse events resulting in any of the following: * death, * life-threatening adverse event, * persistent or significant disability/incapacity, and/or * a major open surgical intervention which is performed by a surgeon under general anesthesia
Time frame: Through 180 days
Population: The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150). The analysis population included the subjects who were available at the time of evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PDA Closure | Safety Endpoint: The Rate of Major Complications After an Attempted ADO II AS Device Implant | IDE Cohort | 0 percentage of participants |
| PDA Closure | Safety Endpoint: The Rate of Major Complications After an Attempted ADO II AS Device Implant | CAP Cohort | 2.8 percentage of participants |
Secondary
The Rate of Significant Obstruction of the Pulmonary Artery or Aorta
The rate of significant obstruction of the pulmonary artery or aorta through the 6-month follow-up visit per the following definitions: 1. Significant obstruction of the left pulmonary artery is defined as less than 30% flow to the left lung by lung perfusion scan or a peak instantaneous gradient in left pulmonary artery ≥35 mmHg by echocardiogram if lung perfusion scan is not available. OR 2. Significant obstruction of the aorta is defined as a gradient of ≥20 mmHg in the aortic isthmus by invasive aortic catheterization or a mean gradient ≥20 mmHg in the aortic isthmus by echocardiogram if invasive aortic catheterization is not available.
Time frame: Through 6 month follow-up visit
Population: The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150). The analysis population included the subjects who were available at the time of evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PDA Closure | The Rate of Significant Obstruction of the Pulmonary Artery or Aorta | IDE Cohort | 2.4 percentage of participants |
| PDA Closure | The Rate of Significant Obstruction of the Pulmonary Artery or Aorta | CAP Cohort | 0 percentage of participants |