ADO II: AMPLATZER Duct Occluder II Clinical Study

• Sponsor: Abbott Medical Devices (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00713700
• Collaborator: (none)
• Enrollment: 192
• Locations: 25
• Arm: 1
• Duration (Months): 98.1
• Patients Per Site: 7.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The objective of this study is to investigate the safety and effectiveness of the ADO II in patients with a PDA.

Condition or Disease	Intervention/Treatment	Phase
Patent Ductus Arteriosus	Device: AMPLATZER Duct Occluder II	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 192 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Closure of Patent Ductus Arteriosus With the AMPLATZER DUCT Occluder II
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Oct 5, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Device	Device: AMPLATZER Duct Occluder II; AMPLATZER Duct Occluder II

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 18 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital and Health Center	San Diego	California	United States	92123
2	University of California San Francisco Hospital	San Francisco	California	United States	94143-0544
3	The Children's Hospital - Denver	Aurora	Colorado	United States	80045
4	Alfred I. DuPont Hospital for Children -Nemours Cardiac Center	Wilmington	Delaware	United States	19803
5	Children's National Medical Center	Washington	District of Columbia	United States	20010
6	Memorial Regional Hospital (Joe DiMaggio Children's Hospital)	Hollywood	Florida	United States	33021
7	Children's Healthcare of Atlanta	Atlanta	Georgia	United States	30322
8	Riley Hospital for Children	Indianapolis	Indiana	United States	46202
9	Children's Hospital Boston	Boston	Massachusetts	United States	02115
10	University of Minnesota	Minneapolis	Minnesota	United States	55455
11	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216-4505
12	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
13	The Children's Hospital Montefiore	Bronx	New York	United States	10467
14	Mount Sinai School of Medicine	New York	New York	United States	10029
15	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229-3039
16	The Children's Hospital at Cleveland Clinic	Cleveland	Ohio	United States	44195
17	Nationwide Children's Hospital	Columbus	Ohio	United States	43205
18	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104-4399
19	Medical University of South Carolina	Charleston	South Carolina	United States	29425
20	Vanderbilt Children's Hospital	Nashville	Tennessee	United States	37232-9119
21	University of Texas SW Medical Center	Dallas	Texas	United States	75235
22	Texas Children's Hospital	Houston	Texas	United States	77030-2399
23	Primary Children's Medical Center	Salt Lake City	Utah	United States	84113
24	Children's Hospital and Regional Medical Center	Seattle	Washington	United States	98105-0371
25	Children's Hospital of Wisconsin	Milwaukee	Wisconsin	United States	53226

Sponsors and Collaborators

• Abbott Medical Devices

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT00713700
• Other Study ID Numbers: CL00233
• First Posted: Jul 11, 2008
• Last Update Posted: Feb 4, 2019
• Last Verified: Jan 1, 2019

• Keywords provided by Abbott Medical Devices: patent ductus arteriosus; PDA
• Additional relevant MeSH terms: Ductus Arteriosus, Patent

Study Results

Participant Flow

Arm/Group Title	Device
Arm/Group Description	AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II
Period Title: Overall Study
STARTED	192
COMPLETED	188
NOT COMPLETED	4

Baseline Characteristics

Arm/Group Title	Device
Arm/Group Description	AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II
Overall Participants	192
Age (Count of Participants)
<=18 years	192 100%
Between 18 and 65 years	0 0%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	4.4 (4.2)
Sex: Female, Male (Count of Participants)
Female	120 62.5%
Male	72 37.5%
Region of Enrollment (participants) [Number]
United States	192 100%

Outcome Measures

1. Primary Outcome

Title	The Primary Safety Endpoint is the Rate of Device and Procedure Related Serious Adverse Events (SAE) 180 Days Post Procedure.
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Device
Arm/Group Description	AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II
Measure Participants	188
Number (95% Confidence Interval) [percentage of participants]	1.6 0.8%

2. Primary Outcome

Title	The Primary Effectiveness Endpoint is the Rate of Complete Closure of the Ductus Arteriosus at the Six-month Follow-up.
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Device
Arm/Group Description	AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II
Measure Participants	166
Number (95% Confidence Interval) [percentage of participants]	98.19 51.1%

Adverse Events

Arm/Group Title	Device
Arm/Group Description	AMPLATZER Duct Occluder II : AMPLATZER Duct Occluder II
All Cause Mortality
	Device
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Device
	Affected / at Risk (%)	# Events
Total	3/192 (1.6%)
Injury, poisoning and procedural complications
Device Embolization	1/192 (0.5%)	1
Sinus tachycardia	1/192 (0.5%)	1
Surgical and medical procedures
Residual shunt requiring closure	2/192 (1%)	2
Other (Not Including Serious) Adverse Events
	Device
	Affected / at Risk (%)	# Events
Total	19/192 (9.9%)
General disorders
Pain	19/192 (9.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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