Trial Outcomes & Findings for AMPLATZER Duct Occluder II Additional Sizes (NCT NCT03055858)
NCT ID: NCT03055858
Last Updated: 2025-02-11
Results Overview
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
COMPLETED
NA
200 participants
Through 180 days
2025-02-11
Participant Flow
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.
Participant milestones
| Measure |
PDA Closure
ADO II AS (PDA closure): Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).
|
|---|---|
|
Overall Study
STARTED
|
200
|
|
Overall Study
IDE
|
136
|
|
Overall Study
CAP
|
46
|
|
Overall Study
COMPLETED
|
156
|
|
Overall Study
NOT COMPLETED
|
44
|
Reasons for withdrawal
| Measure |
PDA Closure
ADO II AS (PDA closure): Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).
|
|---|---|
|
Overall Study
Death
|
9
|
|
Overall Study
Withdrawal by Subject
|
11
|
|
Overall Study
Lost to Follow-up
|
6
|
|
Overall Study
Missed Follow-Up Visits
|
18
|
Baseline Characteristics
The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150)
Baseline characteristics by cohort
| Measure |
PDA Closure
n=200 Participants
ADO II AS (PDA closure): Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).
|
|---|---|
|
Age, Continuous
IDE Cohort
|
16.37 months
STANDARD_DEVIATION 32.45 • n=50 Participants • The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150)
|
|
Age, Continuous
CAP Cohort
|
13.10 months
STANDARD_DEVIATION 34.23 • n=150 Participants • The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150)
|
|
Sex: Female, Male
IDE Cohort · Female
|
29 Participants
n=50 Participants • The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150)
|
|
Sex: Female, Male
IDE Cohort · Male
|
21 Participants
n=50 Participants • The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150)
|
|
Sex: Female, Male
CAP Cohort · Female
|
69 Participants
n=150 Participants • The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150)
|
|
Sex: Female, Male
CAP Cohort · Male
|
81 Participants
n=150 Participants • The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150)
|
|
Ethnicity (NIH/OMB)
IDE Cohort · Hispanic or Latino
|
1 Participants
n=50 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
|
|
Ethnicity (NIH/OMB)
IDE Cohort · Not Hispanic or Latino
|
44 Participants
n=50 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
|
|
Ethnicity (NIH/OMB)
IDE Cohort · Unknown or Not Reported
|
5 Participants
n=50 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
|
|
Ethnicity (NIH/OMB)
CAP Cohort · Hispanic or Latino
|
16 Participants
n=150 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
|
|
Ethnicity (NIH/OMB)
CAP Cohort · Not Hispanic or Latino
|
129 Participants
n=150 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
|
|
Ethnicity (NIH/OMB)
CAP Cohort · Unknown or Not Reported
|
5 Participants
n=150 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
|
|
Race (NIH/OMB)
IDE Cohort · American Indian or Alaska Native
|
0 Participants
n=50 Participants • The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150)
|
|
Race (NIH/OMB)
IDE Cohort · Asian
|
0 Participants
n=50 Participants • The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150)
|
|
Race (NIH/OMB)
IDE Cohort · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=50 Participants • The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150)
|
|
Race (NIH/OMB)
IDE Cohort · Black or African American
|
21 Participants
n=50 Participants • The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150)
|
|
Race (NIH/OMB)
IDE Cohort · White
|
21 Participants
n=50 Participants • The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150)
|
|
Race (NIH/OMB)
IDE Cohort · More than one race
|
0 Participants
n=50 Participants • The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150)
|
|
Race (NIH/OMB)
IDE Cohort · Unknown or Not Reported
|
8 Participants
n=50 Participants • The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150)
|
|
Race (NIH/OMB)
CAP Cohort · American Indian or Alaska Native
|
1 Participants
n=150 Participants • The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150)
|
|
Race (NIH/OMB)
CAP Cohort · Asian
|
10 Participants
n=150 Participants • The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150)
|
|
Race (NIH/OMB)
CAP Cohort · Native Hawaiian or Other Pacific Islander
|
1 Participants
n=150 Participants • The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150)
|
|
Race (NIH/OMB)
CAP Cohort · Black or African American
|
55 Participants
n=150 Participants • The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150)
|
|
Race (NIH/OMB)
CAP Cohort · White
|
57 Participants
n=150 Participants • The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150)
|
|
Race (NIH/OMB)
CAP Cohort · More than one race
|
5 Participants
n=150 Participants • The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150)
|
|
Race (NIH/OMB)
CAP Cohort · Unknown or Not Reported
|
21 Participants
n=150 Participants • The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150)
|
|
Region of Enrollment
United States
|
200 participants
n=200 Participants
|
|
PDA Length
IDE
|
8.28 mm
STANDARD_DEVIATION 2.70 • n=50 Participants • The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150)
|
|
PDA Length
CAP
|
9.51 mm
STANDARD_DEVIATION 2.98 • n=150 Participants • The ADO II AS IDE study composed of 2 cohorts including IDE (n=50) and CAP (n=150)
|
PRIMARY outcome
Timeframe: Through 180 daysPopulation: 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.
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
Outcome measures
| Measure |
PDA Closure
n=194 Participants
ADO II AS (PDA closure): Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).
|
|---|---|
|
Safety Endpoint: The Rate of Major Complications After an Attempted ADO II AS Device Implant
IDE Cohort
|
0 percentage of participants
Interval 0.0 to 7.11
|
|
Safety Endpoint: The Rate of Major Complications After an Attempted ADO II AS Device Implant
CAP Cohort
|
2.8 percentage of participants
Interval 0.76 to 6.96
|
PRIMARY outcome
Timeframe: At the 6-month follow-upPopulation: 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.
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).
Outcome measures
| Measure |
PDA Closure
n=173 Participants
ADO II AS (PDA closure): Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).
|
|---|---|
|
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
Interval 91.96 to 100.0
|
|
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
Interval 95.76 to 99.98
|
SECONDARY outcome
Timeframe: Through 6 month follow-up visitPopulation: 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.
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.
Outcome measures
| Measure |
PDA Closure
n=171 Participants
ADO II AS (PDA closure): Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).
|
|---|---|
|
The Rate of Significant Obstruction of the Pulmonary Artery or Aorta
IDE Cohort
|
2.4 percentage of participants
Interval 0.06 to 12.86
|
|
The Rate of Significant Obstruction of the Pulmonary Artery or Aorta
CAP Cohort
|
0 percentage of participants
Interval 0.0 to 2.8
|
Adverse Events
PDA Closure
Serious adverse events
| Measure |
PDA Closure
n=200 participants at risk
ADO II AS (PDA closure): Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.50%
1/200 • 6 months
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.50%
1/200 • 6 months
|
|
Injury, poisoning and procedural complications
Procedural Blood Loss
|
0.50%
1/200 • 6 months
|
|
Cardiac disorders
Coarctation of Aorta
|
0.50%
1/200 • 6 months
|
|
Cardiac disorders
Obstruction of The Aorta
|
0.50%
1/200 • 6 months
|
|
Blood and lymphatic system disorders
Pulmonary Hypertension
|
0.50%
1/200 • 6 months
|
|
General disorders
Death
|
1.0%
2/200 • 6 months
|
|
General disorders
Desaturation
|
0.50%
1/200 • 6 months
|
|
Injury, poisoning and procedural complications
Device Migration
|
0.50%
1/200 • 6 months
|
|
General disorders
Death Related to Liver Failure and Chronic Lung Disease
|
0.50%
1/200 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Progressive Pulmonary Disease
|
0.50%
1/200 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Compromise
|
0.50%
1/200 • 6 months
|
|
Gastrointestinal disorders
Necrotizing Enterocolitis
|
0.50%
1/200 • 6 months
|
|
Blood and lymphatic system disorders
Bleeding
|
0.50%
1/200 • 6 months
|
|
Injury, poisoning and procedural complications
Device Embolization
|
0.50%
1/200 • 6 months
|
|
Nervous system disorders
Stroke
|
0.50%
1/200 • 6 months
|
|
Nervous system disorders
Left Vocal Cord Paralysis
|
0.50%
1/200 • 6 months
|
Other adverse events
| Measure |
PDA Closure
n=200 participants at risk
ADO II AS (PDA closure): Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.0%
2/200 • 6 months
|
|
Injury, poisoning and procedural complications
Device Embolization
|
2.5%
5/200 • 6 months
|
|
General disorders
Fever
|
0.50%
1/200 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
0.50%
1/200 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Compromise
|
0.50%
1/200 • 6 months
|
|
Blood and lymphatic system disorders
Anemia Requiring Transfusion
|
0.50%
1/200 • 6 months
|
|
General disorders
Hoarse Cry
|
0.50%
1/200 • 6 months
|
|
Cardiac disorders
Tissue from Left Side of Atrial Septum
|
0.50%
1/200 • 6 months
|
|
Cardiac disorders
Arrhythmia
|
0.50%
1/200 • 6 months
|
|
Blood and lymphatic system disorders
Hematoma
|
0.50%
1/200 • 6 months
|
|
Blood and lymphatic system disorders
Hypotension
|
0.50%
1/200 • 6 months
|
|
Infections and infestations
Infection
|
0.50%
1/200 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Obstruction of The Pulmonary Artery
|
1.0%
2/200 • 6 months
|
|
Blood and lymphatic system disorders
Thrombus
|
0.50%
1/200 • 6 months
|
|
Cardiac disorders
Valve Damage
|
0.50%
1/200 • 6 months
|
|
Cardiac disorders
Valvular Regurgitation
|
2.5%
5/200 • 6 months
|
|
Vascular disorders
Vascular Occlusion
|
1.0%
2/200 • 6 months
|
|
Blood and lymphatic system disorders
Vessel Damage
|
0.50%
1/200 • 6 months
|
|
Blood and lymphatic system disorders
Anemia
|
0.50%
1/200 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Deterioration in Resp Status
|
0.50%
1/200 • 6 months
|
|
Cardiac disorders
Right bundle branch block
|
0.50%
1/200 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60