Trial record 18 of 172 for:    "Children's Hospital of Wisconsin"

AMPLATZER Duct Occluder II Clinical Study (ADO II)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AGA Medical Corporation
ClinicalTrials.gov Identifier:
NCT00713700
First received: July 9, 2008
Last updated: October 25, 2013
Last verified: October 2013
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 AGA Medical Corporation:

Primary Outcome Measures:
  • The Primary Safety Endpoint Will be the Rate of Device and Procedure Related SAE 180 Days Post Procedure. [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
  • The Primary Effectiveness Endpoint Will be the Rate of Complete Closure of the Ductus Arteriosus at the Six-month Follow-up. [ Time Frame: 180 days ] [ Designated as safety issue: No ]

Enrollment: 192
Study Start Date: August 2008
Estimated Study Completion Date: July 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

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00713700

  Show 25 Study Locations
Sponsors and Collaborators
AGA Medical Corporation
  More Information

No publications provided

Responsible Party: AGA Medical Corporation
ClinicalTrials.gov Identifier: NCT00713700     History of Changes
Other Study ID Numbers: CL00233
Study First Received: July 9, 2008
Results First Received: October 25, 2013
Last Updated: October 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AGA Medical Corporation:
patent ductus arteriosus
PDA

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

ClinicalTrials.gov processed this record on April 14, 2014