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AMPLATZER Duct Occluder II Clinical Study (ADO II)

Primary Purpose

Patent Ductus Arteriosus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AMPLATZER Duct Occluder II
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patent Ductus Arteriosus focused on measuring patent ductus arteriosus, PDA

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Hospital and Health Center
  • University of California San Francisco Hospital
  • The Children's Hospital - Denver
  • Alfred I. DuPont Hospital for Children -Nemours Cardiac Center
  • Children's National Medical Center
  • Memorial Regional Hospital (Joe DiMaggio Children's Hospital)
  • Children's Healthcare of Atlanta
  • Riley Hospital for Children
  • Children's Hospital Boston
  • University of Minnesota
  • University of Mississippi Medical Center
  • Washington University School of Medicine
  • The Children's Hospital Montefiore
  • Mount Sinai School of Medicine
  • Cincinnati Children's Hospital Medical Center
  • The Children's Hospital at Cleveland Clinic
  • Nationwide Children's Hospital
  • The Children's Hospital of Philadelphia
  • Medical University of South Carolina
  • Vanderbilt Children's Hospital
  • University of Texas SW Medical Center
  • Texas Children's Hospital
  • Primary Children's Medical Center
  • Children's Hospital and Regional Medical Center
  • Children's Hospital of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Device

Arm Description

Outcomes

Primary Outcome Measures

The Primary Safety Endpoint is the Rate of Device and Procedure Related Serious Adverse Events (SAE) 180 Days Post Procedure.
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.
The Primary Effectiveness Endpoint is the Rate of Complete Closure of the Ductus Arteriosus at the Six-month Follow-up.
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.

Secondary Outcome Measures

Full Information

First Posted
July 9, 2008
Last Updated
January 31, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00713700
Brief Title
AMPLATZER Duct Occluder II Clinical Study
Acronym
ADO II
Official Title
Closure of Patent Ductus Arteriosus With the AMPLATZER DUCT Occluder II
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 5, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patent Ductus Arteriosus
Keywords
patent ductus arteriosus, PDA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Device
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
AMPLATZER Duct Occluder II
Intervention Description
AMPLATZER Duct Occluder II
Primary Outcome Measure Information:
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Children's Hospital and Health Center
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
University of California San Francisco Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0544
Country
United States
Facility Name
The Children's Hospital - Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Alfred I. DuPont Hospital for Children -Nemours Cardiac Center
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Memorial Regional Hospital (Joe DiMaggio Children's Hospital)
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4505
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
The Children's Hospital Montefiore
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Facility Name
The Children's Hospital at Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4399
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt Children's Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-9119
Country
United States
Facility Name
University of Texas SW Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-2399
Country
United States
Facility Name
Primary Children's Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
Children's Hospital and Regional Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105-0371
Country
United States
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Learn more about this trial

AMPLATZER Duct Occluder II Clinical Study

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