ADO II AS: AMPLATZER Duct Occluder II Additional Sizes

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03055858
• Collaborator: (none)
• Enrollment: 200
• Locations: 9
• Arm: 1
• Anticipated Duration (Months): 64.9
• Patients Per Site: 22.2
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Patent Ductus Arteriosus	Device: ADO II AS (PDA closure)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: ADO II AS deviceADO II AS device
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: AMPLATZER Duct Occluder II Additional Sizes (ADO II AS) Clinical Study
• Actual Study Start Date: Jun 5, 2017
• Actual Primary Completion Date: Sep 25, 2019
• Anticipated Study Completion Date: Oct 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PDA closure	Device: ADO II AS (PDA closure); Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).

Outcome Measures

Primary Outcome Measures

1. 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

2. 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 Outcome Measures

1. 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: 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 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Days and Older
• Sexes Eligible for Study: All
• Accepts 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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars Sinai Medical Center	Los Angeles	California	United States	90048
2	Arnold Palmer Hospital	Orlando	Florida	United States	32806
3	Children's Hospital of Michigan	Detroit	Michigan	United States	48201
4	St. Louis Children's Hospital	Saint Louis	Missouri	United States	63110
5	Nationwide Children's Hospital	Columbus	Ohio	United States	43205
6	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
7	Methodist LeBonheur Healthcare	Memphis	Tennessee	United States	38105
8	Texas Children's Hospital	Houston	Texas	United States	77030
9	Seattle Children's Hospital	Seattle	Washington	United States	98105

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

• Principal Investigator: Evan Zahn, MD, Cedars-Sinai Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 2, 2018

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT03055858
• Other Study ID Numbers: SJM-CIP-10171
• First Posted: Feb 16, 2017
• Last Update Posted: Jul 29, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Abbott Medical Devices: PDA, ADO II AS
• Additional relevant MeSH terms: Ductus Arteriosus, Patent

Study Results

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.
Pre-assignment Detail	Among the 50 subjects in the IDE cohort, 4 subjects did not receive the study device and were withdrawn per protocol following completion of the 1-month follow-up visit. Of the 150 subjects in CAP cohort, 139 completed the 6 months follow up.

Arm/Group Title	PDA Closure
Arm/Group Description	ADO II AS (PDA closure): Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).
Period Title: Overall Study
STARTED	200
IDE Cohort	50
CAP Cohort	150
COMPLETED	194
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	PDA Closure
Arm/Group Description	ADO II AS (PDA closure): Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).
Overall Participants	200
Age (months) [Mean (Standard Deviation) ]
IDE Cohort	16.37 (32.45)
CAP Cohort	13.10 (34.23)
Sex: Female, Male (Count of Participants)
Female	29 14.5%
Male	21 10.5%
Female	69 34.5%
Male	81 40.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	21 10.5%
White	21 10.5%
More than one race	0 0%
Unknown or Not Reported	8 4%
American Indian or Alaska Native	1 0.5%
Asian	10 5%
Native Hawaiian or Other Pacific Islander	1 0.5%
Black or African American	55 27.5%
White	57 28.5%
More than one race	5 2.5%
Unknown or Not Reported	21 10.5%
Region of Enrollment (participants) [Number]
United States	200 100%

Outcome Measures

1. Primary Outcome

Title	Safety Endpoint: The Rate of Major Complications After an Attempted ADO II AS Device Implant
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	PDA Closure
Arm/Group Description	ADO II AS (PDA closure): Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).
Measure Participants	194
IDE Cohort	0 0%
CAP Cohort	2.8 1.4%

2. Primary Outcome

Title	Effectiveness Endpoint: The Rate of Effective Closure of the Ductus Arteriosus Among Subjects With a Successful ADO II AS Implant
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	PDA Closure
Arm/Group Description	ADO II AS (PDA closure): Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).
Measure Participants	173
IDE Cohort	100 50%
CAP Cohort	99.2 49.6%

3. Secondary Outcome

Title	The Rate of Significant Obstruction of the Pulmonary Artery or Aorta
Description	The rate of significant obstruction of the pulmonary artery or aorta through the 6-month follow-up visit per the following definitions: 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 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

Outcome Measure Data

Analysis Population Description

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/Group Title	PDA Closure
Arm/Group Description	ADO II AS (PDA closure): Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).
Measure Participants	171
IDE Cohort	2.4 1.2%
CAP Cohort	0 0%

Adverse Events

Time Frame	6 months
Arm/Group Title	PDA Closure
Arm/Group Description	ADO II AS (PDA closure): Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).
All Cause Mortality
	PDA Closure
	Affected / at Risk (%)	# Events
Total	13/200 (6.5%)
Serious Adverse Events
	PDA Closure
	Affected / at Risk (%)	# Events
Total	13/200 (6.5%)
Blood and lymphatic system disorders
Anemia	1/200 (0.5%)
Hemolysis	1/200 (0.5%)
Procedural Blood Loss	1/200 (0.5%)
Cardiac disorders
Coarctation of Aorta	1/200 (0.5%)
Obstruction of The Aorta	1/200 (0.5%)
Pulmonary Hypertension	1/200 (0.5%)
Gastrointestinal disorders
Necrotizing Enterocolitis	1/200 (0.5%)
General disorders
Death	2/200 (1%)
Desaturation	1/200 (0.5%)
Injury, poisoning and procedural complications
Device Migration	1/200 (0.5%)
Respiratory, thoracic and mediastinal disorders
Death Related to Liver Failure and Chronic Lung Disease	1/200 (0.5%)
Progressive Pulmonary Disease	1/200 (0.5%)
Respiratory Compromise	1/200 (0.5%)
Other (Not Including Serious) Adverse Events
	PDA Closure
	Affected / at Risk (%)	# Events
Total	26/200 (13%)
Blood and lymphatic system disorders
Anemia Requiring Transfusion	1/200 (0.5%)
Hematoma	1/200 (0.5%)
Thrombus	1/200 (0.5%)
Anemia	1/200 (0.5%)
Cardiac disorders
Tissue from Left Side of Atrial Septum	1/200 (0.5%)
Arrhythmia	1/200 (0.5%)
Valve Damage	1/200 (0.5%)
Valvular Regurgitation	5/200 (2.5%)
Right bundle branch block	1/200 (0.5%)
General disorders
Fever	1/200 (0.5%)
Hoarse Cry	1/200 (0.5%)
Infections and infestations
Infection	1/200 (0.5%)
Injury, poisoning and procedural complications
Device Embolization	5/200 (2.5%)
Respiratory, thoracic and mediastinal disorders
Atelectasis	2/200 (1%)
Pulmonary Edema	1/200 (0.5%)
Respiratory Compromise	1/200 (0.5%)
Obstruction of The Pulmonary Artery	2/200 (1%)
Deterioration in Resp Status	1/200 (0.5%)
Vascular disorders
Hypotension	1/200 (0.5%)
Vascular Occlusion	2/200 (1%)
Vessel Damage	1/200 (0.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.