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AMPLATZER Duct Occluder II Additional Sizes (ADO II AS)

This study is currently recruiting participants.
Verified September 2017 by St. Jude Medical
Sponsor:
ClinicalTrials.gov Identifier:
NCT03055858
First Posted: February 16, 2017
Last Update Posted: September 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Jude Medical
  Purpose

The ADO II AS Study is a single arm, prospective, multicenter, nonrandomized, open-label study to characterize the safety and effectiveness of the ADO II AS device in patients with a patent ductus arteriosus (PDA). Subjects will be implanted with the ADO II AS device using a transcatheter femoral vessel approach under fluoroscopic and echocardiographic guidance.

To account for subject dropout, up to 50 subjects will be enrolled in this clinical investigation. The clinical investigation will be conducted at up to 10 centers in the United States.

Subjects participating in this clinical investigation will be followed for 3 years. The expected duration of enrollment is 18 months. The total duration of the clinical investigation is expected to be 4.5 years.


Condition Intervention
Patent Ductus Arteriosus Device: ADO II AS (PDA closure)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
ADO II AS device
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AMPLATZER Duct Occluder II Additional Sizes (ADO II AS) Clinical Study

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Safety Endpoint: The rate of major complications after an attempted ADO II AS device implant [ Time Frame: Through 180 days ]
    The rate of major complications after an attempted ADO II AS device implant.

  • Effectiveness Endpoint: The rate of effective closure of the ductus arteriosus among subjects with a successful ADO II AS implant as assessed by the presence of either a Grade 0 or Grade 1 shunt by transthoracic echocardiography. [ Time Frame: At the six-month follow-up ]
    The rate of effective closure of the ductus arteriosus among subjects with a successful ADO II AS implant as assessed by the presence of either a Grade 0 or Grade 1 shunt by transthoracic echocardiography.


Secondary Outcome Measures:
  • Obstruction in left pulmonary artery or aorta: The rate of significant obstruction of the pulmonary artery or aorta [ Time Frame: Through 6 month follow-up visit ]
    The rate of significant obstruction of the pulmonary artery or aorta.


Estimated Enrollment: 50
Actual Study Start Date: June 5, 2017
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PDA closure Device: ADO II AS (PDA closure)
Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of a PDA
  • PDA ≤ 4mm in diameter
  • PDA ≥ 3mm in length
  • Subject (or legally authorized representative) is willing to comply with all pre-procedure, post-procedure, and follow-up testing requirements and provides consent to participate in the clinical study

Exclusion Criteria:

  • Weight < 700 grams at time of the procedure
  • Gestational age < 24 weeks at birth
  • Age < 3 days at time of procedure
  • Coarctation of the aorta
  • Left pulmonary artery stenosis
  • Cardiac output that is dependent on right to left shunt through the patent ductus arteriosus due to pulmonary hypertension
  • Intracardiac thrombus
  • Active infection requiring treatment at the time of implant
  • Female subjects of child bearing potential are either pregnant or desire to become pregnant within six months post implant
  • Other disease process likely to limit survival to less than six (6) months
  • Participating in another study for an investigational drug and/or device that may clinically interfere with this study's endpoints
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055858


Contacts
Contact: Kimberly Behning 651-756-5622 kbehning@sjm.com
Contact: Maren Wagner 651-756-5585 mwagner2@sjm.com

Locations
United States, California
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Jennifer Chang    424-315-2297    jennifer.chang3@cshs.org   
Principal Investigator: Evan Zahn, MD         
United States, Florida
Arnold Palmer Hospital Recruiting
Orlando, Florida, United States, 32806
Contact: Amanda Cowden    321-841-5365    amanda.cowden@orlandohealth.com   
Principal Investigator: David Nykanen, MD         
United States, Michigan
Children's Hospital of Michigan Recruiting
Detroit, Michigan, United States, 48201
Contact: Nancy Sullivan    313-745-1023    nsulliva@med.wayne.edu   
Principal Investigator: Thomas Forbes, MD         
United States, Missouri
St. Louis Children's Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Melissa Allen    314-454-6147    allen_m@kids.wustl.edu   
Principal Investigator: Toby Rockefeller, MD         
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Joanne Chisolm    614-722-4829    joanne.chisolm@nationwidechildrens.org   
Principal Investigator: Darren Berman, MD         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Olivia Martino    267-426-3159    martinoo@email.chop.edu   
Principal Investigator: Matthew Gillespie, MD         
United States, Tennessee
LeBonheur Children's Hospital Active, not recruiting
Memphis, Tennessee, United States, 38105
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Elizabeth McKinney    206-987-3839    elizabeth.mckinney@seattlechildrens.org   
Principal Investigator: Thomas Jones, MD         
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Evan Zahn, MD Cedars-Sinai Medical Center
  More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT03055858     History of Changes
Other Study ID Numbers: SJM-CIP-10171
First Submitted: February 14, 2017
First Posted: February 16, 2017
Last Update Posted: September 15, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by St. Jude Medical:
PDA, ADO II AS

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities