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Closure Of Patent Ductus Arteriosus With the AMPLATZER Duct Occluder the AMPLATZER® Duct Occluder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00583596
First Posted: December 31, 2007
Last Update Posted: February 16, 2015
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
Results First Submitted: January 17, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Patent Ductus Arteriosus (PDA)
Interventions: Device: Device closure with AMPLATZER Duct Occluder
Other: Objective Performance Criteria

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited in medical clinics. The first subject enrolled was September 10, 1999. The last follow-up occurred in the Post Market Surveillance Study on August 29, 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects meeting the inclusion/exclusion criteria of the protocol were included in the original clinical trial.

Reporting Groups
  Description
Long Term Follow-up for Subjects Implanted With the Device Subjects enrolled in IDE study subject to Post Market Surveillance

Participant Flow:   Overall Study
    Long Term Follow-up for Subjects Implanted With the Device
STARTED   436 [1] 
COMPLETED   152 
NOT COMPLETED   284 
Lost to Follow-up                110 
Excluded due to Hurricane Katrina                30 
Death                2 
Withdrawal by Subject                6 
Lost to Follow-up                94 
Data not complete                1 
Not consented                15 
Outside f-up window                26 
[1] Subjects in Phase 2 clinical trial who received the AMPLATZER Duct Occluder.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Long Term Follow-up for Subjects Implanted With the Device Subjects enrolled in IDE study subject to Post Market Surveillance

Baseline Measures
   Long Term Follow-up for Subjects Implanted With the Device 
Overall Participants Analyzed 
[Units: Participants]
 436 
Age 
[Units: Years]
Mean (Standard Deviation)
 6.14  (11.14) 
Gender 
[Units: Participants]
 
Female   298 
Male   138 
Region of Enrollment 
[Units: Participants]
 
United States   436 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Reporting of Late Adverse Events Relating to the Device.   [ Time Frame: Long term follow up for data captured at 5, 6 or 7 years post implant ]

2.  Primary:   Reporting of Late Efficacy Issues Regarding Patent Ductus Arteriosis (PDA) Closure   [ Time Frame: Long term follow up data captured at 5, 6 or 7 years post implant ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jeffrey Mifek
Organization: St. Jude Medical Formally AGA Medical Corporation
phone: 6517565586
e-mail: jmifek@sjm.com



Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00583596     History of Changes
Other Study ID Numbers: AGA-004
G980103
First Submitted: December 20, 2007
First Posted: December 31, 2007
Results First Submitted: January 17, 2014
Results First Posted: July 18, 2014
Last Update Posted: February 16, 2015