AMPLATZER Duct Occluder II Clinical Study (ADO II)

Closure of Patent Ductus Arteriosus With the AMPLATZER DUCT Occluder II

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

Study Overview

• Status: Completed
• Conditions: Patent Ductus Arteriosus
• Intervention / Treatment: Device: AMPLATZER Duct Occluder II

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Children's Hospital and Health Center
    • San Francisco, California, United States, 94143-0544
      • University of California San Francisco Hospital
  • Colorado
    • Aurora, Colorado, United States, 80045
      • The Children's Hospital - Denver
  • Delaware
    • Wilmington, Delaware, United States, 19803
      • Alfred I. DuPont Hospital for Children -Nemours Cardiac Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Medical Center
  • Florida
    • Hollywood, Florida, United States, 33021
      • Memorial Regional Hospital (Joe DiMaggio Children's Hospital)
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Children's Healthcare of Atlanta
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Riley Hospital for Children
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Children's Hospital Boston
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • Mississippi
    • Jackson, Mississippi, United States, 39216-4505
      • University of Mississippi Medical Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New York
    • Bronx, New York, United States, 10467
      • The Children's Hospital Montefiore
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine
  • Ohio
    • Cincinnati, Ohio, United States, 45229-3039
      • Cincinnati Children's Hospital Medical Center
    • Cleveland, Ohio, United States, 44195
      • The Children's Hospital at Cleveland Clinic
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-4399
      • The Children's Hospital of Philadelphia
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Nashville, Tennessee, United States, 37232-9119
      • Vanderbilt Children's Hospital
  • Texas
    • Dallas, Texas, United States, 75235
      • University of Texas SW Medical Center
    • Houston, Texas, United States, 77030-2399
      • Texas Children's Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • Primary Children's Medical Center
  • Washington
    • Seattle, Washington, United States, 98105-0371
      • Children's Hospital and Regional Medical Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Children's Hospital of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 14 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 5, 2016

Study Registration Dates

• First Submitted: July 9, 2008
• First Submitted That Met QC Criteria: July 10, 2008
• First Posted (Estimate): July 11, 2008

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: January 31, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: PDA; patent ductus arteriosus
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Ductus Arteriosus, Patent
• Other Study ID Numbers: CL00233