AMPLATZER Duct Occluder II Additional Sizes

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Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus

Brief Title

AMPLATZER Duct Occluder II Additional Sizes

Official Title

AMPLATZER Duct Occluder II Additional Sizes (ADO II AS) Clinical Study

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.
    



Study Type

Interventional


Primary Outcome

Safety Endpoint: The rate of major complications after an attempted ADO II AS device implant

Secondary Outcome

 Obstruction in left pulmonary artery or aorta: The rate of significant obstruction of the pulmonary artery or aorta

Condition

Patent Ductus Arteriosus

Intervention

ADO II AS (PDA closure)

Study Arms / Comparison Groups

 PDA closure
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

200

Start Date

June 5, 2017

Completion Date

February 2022

Primary Completion Date

September 25, 2019

Eligibility 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
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Evan Zahn, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03055858

Organization ID

SJM-CIP-10171


Responsible Party

Sponsor

Study Sponsor

Abbott Medical Devices


Study Sponsor

Evan Zahn, MD, Principal Investigator, Cedars-Sinai Medical Center


Verification Date

October 2019