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NCT Number: NCT03055858

AMPLATZER Duct Occluder II Additional Sizes

The ADO II AS Study is a single arm, prospective, multicenter, nonrandomized clinical investigation 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.

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Key information

Conditions

Patent Ductus Arteriosus Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Ductus Arteriosus, Patent Heart Defects, Congenital Heart Diseases

Age range

3 day and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars Sinai Medical Center, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

NOTE: This study is enrolling children and all local laws and governing IRB requirements will be followed for obtaining informed consent

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

Treatment and study plan

ADO II AS (PDA closure)

Device

Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).

Primary outcomes

  1. Safety Endpoint: The Rate of Major Complications After an Attempted ADO II AS Device Implant

    Time frame: Through 180 days

    Major complications are defined as device (ADO II AS) or procedure-related adverse events resulting in any of the following:

    • death,
    • life-threatening adverse event,
    • persistent or significant disability/incapacity, and/or
    • a major open surgical intervention which is performed by a surgeon under general anesthesia

  2. Effectiveness Endpoint: The Rate of Effective Closure of the Ductus Arteriosus Among Subjects With a Successful ADO II AS Implant

    Time frame: At the 6-month follow-up

    The primary effectiveness endpoint is 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 (none) or Grade 1 (trivial) shunt at the 6-month follow-up by transthoracic echocardiography (TTE).

Secondary outcomes

  1. 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 through the 6-month follow-up visit per the following definitions:

    • Significant obstruction of the left pulmonary artery is defined as less than 30% flow to the left lung by lung perfusion scan or a peak instantaneous gradient in left pulmonary artery ≥35 mmHg by echocardiogram if lung perfusion scan is not available. OR
    • Significant obstruction of the aorta is defined as a gradient of ≥20 mmHg in the aortic isthmus by invasive aortic catheterization or a mean gradient ≥20 mmHg in the aortic isthmus by echocardiogram if invasive aortic catheterization is not available.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

AMPLATZER Duct Occluder II Additional Sizes Clinical Study

Acronym: ADO II AS

Important dates

Study start
2017
Primary completion
2019
Study completion
2022
First posted
Feb 16, 2017
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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