AMPLATZER Duct Occluder II Clinical Study
ADO II
Closure of Patent Ductus Arteriosus With the AMPLATZER DUCT Occluder II
1 other identifier
interventional
192
1 country
25
Brief Summary
The objective of this study is to investigate the safety and effectiveness of the ADO II in patients with a PDA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2008
Longer than P75 for not_applicable
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2008
CompletedFirst Posted
Study publicly available on registry
July 11, 2008
CompletedStudy Start
First participant enrolled
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedResults Posted
Study results publicly available
December 16, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 5, 2016
CompletedFebruary 4, 2019
January 1, 2019
3.2 years
July 9, 2008
October 25, 2013
January 31, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
180 days
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.
180 days
Study Arms (1)
Device
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Children's Hospital and Health Center
San Diego, California, 92123, United States
University of California San Francisco Hospital
San Francisco, California, 94143-0544, United States
The Children's Hospital - Denver
Aurora, Colorado, 80045, United States
Alfred I. DuPont Hospital for Children -Nemours Cardiac Center
Wilmington, Delaware, 19803, United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
Memorial Regional Hospital (Joe DiMaggio Children's Hospital)
Hollywood, Florida, 33021, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322, United States
Riley Hospital for Children
Indianapolis, Indiana, 46202, United States
Children's Hospital Boston
Boston, Massachusetts, 02115, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
The Children's Hospital Montefiore
The Bronx, New York, 10467, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039, United States
The Children's Hospital at Cleveland Clinic
Cleveland, Ohio, 44195, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104-4399, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Vanderbilt Children's Hospital
Nashville, Tennessee, 37232-9119, United States
University of Texas SW Medical Center
Dallas, Texas, 75235, United States
Texas Children's Hospital
Houston, Texas, 77030-2399, United States
Primary Children's Medical Center
Salt Lake City, Utah, 84113, United States
Children's Hospital and Regional Medical Center
Seattle, Washington, 98105-0371, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ashish Oza
- Organization
- Abbott
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2008
First Posted
July 11, 2008
Study Start
August 1, 2008
Primary Completion
October 1, 2011
Study Completion
October 5, 2016
Last Updated
February 4, 2019
Results First Posted
December 16, 2013
Record last verified: 2019-01