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AMPLATZER Duct Occluder II Clinical Study (ADO II)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00713700
First Posted: July 11, 2008
Last Update Posted: August 23, 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. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Jude Medical
  Purpose
The objective of this study is to investigate the safety and effectiveness of the ADO II in patients with a PDA.

Condition Intervention
Patent Ductus Arteriosus Device: AMPLATZER Duct Occluder II

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Closure of Patent Ductus Arteriosus With the AMPLATZER DUCT Occluder II

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • The Primary Safety Endpoint is the Rate of Device and Procedure Related Serious Adverse Events (SAE) 180 Days Post Procedure. [ Time Frame: 180 days ]

    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.


  • The Primary Effectiveness Endpoint is the Rate of Complete Closure of the Ductus Arteriosus at the Six-month Follow-up. [ Time Frame: 180 days ]
    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.


Enrollment: 192
Study Start Date: August 2008
Study Completion Date: October 5, 2016
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Device Device: AMPLATZER Duct Occluder II
AMPLATZER Duct Occluder II

  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:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  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): NCT00713700


  Show 25 Study Locations
Sponsors and Collaborators
St. Jude Medical
  More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00713700     History of Changes
Other Study ID Numbers: CL00233
First Submitted: July 9, 2008
First Posted: July 11, 2008
Results First Submitted: October 25, 2013
Results First Posted: December 16, 2013
Last Update Posted: August 23, 2017
Last Verified: July 2017

Keywords provided by St. Jude Medical:
patent ductus arteriosus
PDA

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


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