Clinical trial NCT00713700: AMPLATZER Duct Occluder II Clinical Study
Official title: Closure of Patent Ductus Arteriosus With the AMPLATZER DUCT Occluder II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patent Ductus Arteriosus
Keywords: patent ductus arteriosus
PDA
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2008-07-11
Enrollment: 192
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: The Primary Safety Endpoint is the Rate of Device and Procedure Related Serious Adverse Events (SAE) 180 Days Post Procedure.
timeFrame: 180 days
measure: The Primary Effectiveness Endpoint is the Rate of Complete Closure of the Ductus Arteriosus at the Six-month Follow-up.
timeFrame: 180 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Children's Hospital and Health Center
state: California
city: San Francisco
country: United States
facility: University of California San Francisco Hospital
state: California
city: Aurora
country: United States
facility: The Children's Hospital - Denver
state: Colorado
city: Wilmington
country: United States
facility: Alfred I. DuPont Hospital for Children -Nemours Cardiac Center
state: Delaware
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Hollywood
country: United States
facility: Memorial Regional Hospital (Joe DiMaggio Children's Hospital)
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Bronx
country: United States
facility: The Children's Hospital Montefiore
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cleveland
country: United States
facility: The Children's Hospital at Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt Children's Hospital
state: Tennessee
city: Dallas
country: United States
facility: University of Texas SW Medical Center
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Salt Lake City
country: United States
facility: Primary Children's Medical Center
state: Utah
city: Seattle
country: United States
facility: Children's Hospital and Regional Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
References: