Trial record 19 of 53 for:    "Patent ductus arteriosus"

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

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
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, see Learn About Clinical Studies.

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 July 22, 2014