AMPLATZER Duct Occluder II Clinical Study

Patent Ductus Arteriosus Clinical Trial

— ADO II  

Official title:

Closure of Patent Ductus Arteriosus With the AMPLATZER DUCT Occluder II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00713700
• Other study ID #: CL00233
• Status: Completed
• Phase: N/A
• Start date: August 2008
• Est. completion date: October 5, 2016

Study information

• Verified date: January 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: October 5, 2016
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Patent Ductus Arteriosus

Intervention

Device:
• AMPLATZER Duct Occluder II
AMPLATZER Duct Occluder II

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	The Children's Hospital - Denver	Aurora	Colorado
United States	Children's Hospital Boston	Boston	Massachusetts
United States	The Children's Hospital Montefiore	Bronx	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	The Children's Hospital at Cleveland Clinic	Cleveland	Ohio
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	University of Texas SW Medical Center	Dallas	Texas
United States	Memorial Regional Hospital (Joe DiMaggio Children's Hospital)	Hollywood	Florida
United States	Texas Children's Hospital	Houston	Texas
United States	Riley Hospital for Children	Indianapolis	Indiana
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	Vanderbilt Children's Hospital	Nashville	Tennessee
United States	Mount Sinai School of Medicine	New York	New York
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Primary Children's Medical Center	Salt Lake City	Utah
United States	Children's Hospital and Health Center	San Diego	California
United States	University of California San Francisco Hospital	San Francisco	California
United States	Children's Hospital and Regional Medical Center	Seattle	Washington
United States	Children's National Medical Center	Washington	District of Columbia
United States	Alfred I. DuPont Hospital for Children -Nemours Cardiac Center	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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