|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P020024 S052/ PAS001 |
| Date Original Protocol Accepted |
01/11/2019
|
| Date Current Protocol Accepted |
|
| Study Name |
Continued FU of IDE/CAP cohort
|
| Device Name |
AMPLATZER Piccolo Occluder
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Neonate: 1-28 days,
Infant: 29 days-2 yrs,
Child: 2-12 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Continued follow-up of IDE pivotal and continued access cohorts. The objective of this study is to evaluate the safety and effectiveness of the AMPLATZER Piccolo Occluder annually through 3 years post-procedure.
|
| Study Population |
Patients with a patent ductus arteriosus. The study is comprised of two cohorts: patients = 2 kg and patients > 2 kg in weight. The majority of subjects are less than 2 years old.
|
| Sample Size |
The premarket study enrolled a total of 50 subjects, 18 in the = 2kg cohort and 32 in the > 2kg cohort.
|
| Key Study Endpoints |
The primary safety endpoint for the study is the rate of major complications through 180 days after an attempted ADO II AS device implant. Major complications are defined as device or procedure-related adverse events resulting in any of the following:
o Death
o Life-threatening adverse event
o Persistent or significant disability/incapacity, and/or
o A major open surgical intervention performed by a surgeon under general anesthesia
The primary effectiveness endpoint is the rate of effective closure of the ductus arteriosus among patients with a successful ADO II AS implant as assessed by the presence of either a Grade 0 or Grade 1 shunt at the six-month follow-up by transthoracic echocardiography.
The secondary endpoint is 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.
In addition, the study will record implant success, major and minor complications, death, and adverse events.
|
| Follow-up Visits and Length of Follow-up |
Follow up will continue annually through 3 years post-procedure.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
IDE Pivotal Cohort (IDE): The study enrolled a total of 50 subjects in the IDE cohort.
CAP Cohort (CAP): The study enrolled a total of 150 CAP cohort subjects at 9 investigational sites in the US.
|
| Actual Number of Sites Enrolled |
IDE Cohort - 8 investigational sites in the U.S.
CAP Cohort - 9 investigational sites in the U.S.
|
| Patient Follow-up Rate |
IDE Pivotal Cohort: 42/46 (91.3%) completed the 36-month visit
CAP Cohort: 114/136 (83.8%) completed the 36-month visit
|
| Final Safety Findings |
Primary Safety Endpoint (IDE & CAP) is defined as the rate of major complications through 180 days after an attempted Amplatzer Piccolo Occluder implant.
IDE: Zero (0.0%, 0/50) major complications were reported No deaths were reported.
CAP: Four subjects weighing = 2 kg (2.8%, 4/144) experienced a major complication. Zero subjects weighing > 2 kg (0%, 0/144) experienced a major complication. Six subjects with a successful implant withdrew before 180 days without an event and are excluded from the analysis.
CAP:
Death: There were nine deaths reported among CAP cohort subjects. Eight subject deaths were adjudicated as not related to the device or implant procedure.
|
| Final Effect Findings |
Primary Effectiveness Endpoint (IDE & CAP) is defined as the rate of effective closure of the ductus arteriosus among patients with a successful Amplatzer Piccolo Occluder implant at the 6-month follow-up by transthoracic echocardiography (TTE) as assessed by the Echocardiography Core Laboratory.
IDE: All subjects (100%, 46/46) with an evaluable echocardiogram achieved effective closure at 6 months.
CAP: All subjects = 2 kg, and 98.2% of subjects > 2 kg achieved effective closure at 6 months post-procedure, for an overall rate of effective closure of 99.2% (128/129).
Secondary Endpoint (IDE & CAP) is defined as the rate of significant obstruction of the pulmonary artery or aorta through the 6- month follow-up.
IDE: One of the 41 evaluable subjects (2.4%, 1/41) had significant obstruction of the aorta.
CAP: No subject (0%, 0/130) had significant obstruction of the LPA or aorta.
|
| Study Strengths & Weaknesses |
A strength of both studies (IDE & CAP) is that both studies followed the subjects through 3 years post-procedure and provides longer term safety and effectiveness results of the Amplatzer Piccolo Occluder device.
A weakness of both studies (IDE & CAP) is that both studies are single-arm (non-randomized)
studies.
|
| Recommendations for Labeling Changes |
A labeling change is recommended to add the long-term safety and efficacy results from these studies.
|
