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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AGA Medical Corporation
ClinicalTrials.gov Identifier:
NCT00583596
First received: December 20, 2007
Last updated: July 17, 2014
Last verified: June 2014
Results First Received: January 17, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Patent Ductus Arteriosus (PDA)
Interventions: Device: Device closure with AMPLATZER Duct Occluder
Other: Objective Performance Criteria

  Participant Flow
  Hide Participant Flow

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
  Hide Baseline Characteristics

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  
Number of Participants  
[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
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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


No publications provided


Responsible Party: AGA Medical Corporation
ClinicalTrials.gov Identifier: NCT00583596     History of Changes
Other Study ID Numbers: AGA-004, G980103
Study First Received: December 20, 2007
Results First Received: January 17, 2014
Last Updated: July 17, 2014
Health Authority: United States: Food and Drug Administration