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AMPLATZER Duct Occluder II Additional Sizes (ADO II AS)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03055858
Recruitment Status : Active, not recruiting
First Posted : February 16, 2017
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:

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. Up to an additional 150 subjects may be enrolled under continued access. 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 or disease Intervention/treatment Phase
Patent Ductus Arteriosus Device: ADO II AS (PDA closure) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
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
Actual Study Start Date : June 5, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Adenosine

Arm Intervention/treatment
Experimental: PDA closure Device: ADO II AS (PDA closure)
Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).




Primary Outcome Measures :
  1. 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.

  2. 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 :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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
  • 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

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


Locations
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United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Florida
Arnold Palmer Hospital
Orlando, Florida, United States, 32806
United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
United States, Missouri
St. Louis Children's Hospital
Saint Louis, Missouri, United States, 63110
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
LeBonheur Children's Hospital
Memphis, Tennessee, United States, 38105
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Evan Zahn, MD Cedars-Sinai Medical Center

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT03055858     History of Changes
Other Study ID Numbers: SJM-CIP-10171
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Abbott Medical Devices:
PDA, ADO II AS
Additional relevant MeSH terms:
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Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities