Long Term Results of 450 Percutaneous Closures of PDA in a Single Center

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Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus

Brief Title

Long Term Results of 450 Percutaneous Closures of PDA in a Single Center

Official Title

Long Term Results of 450 Percutaneous Closures of PDA in a Single Center

Brief Summary

      Percutaneous closure is one of the methods used to treat, among other congenital heart
      disorder, Persistent Ductus Arteriosus (PDA) in children and adults. During the years
      1998-2013 four hundred and fifty patients were catheterized in the department of pediatric
      cardiology and congenital heart diseases in Rambam health care campus, using various devices.

      In this retrospective research, the investigators analyze data from patients' medical files,
      to estimate and define the correlation between the patients' demographic and morphologic data
      to the type and size of chosen closure device.

      Aim of study:

      To create an algorithm that can be used to choose the proper device for percutaneous closure
      of the PDA, based on the characteristics of the patient and the PDA type.
    

Detailed Description

      The investigators analyze the demographic characteristics of patients before the procedure
      (Age, gender, weight, height, co-morbidities etc.), the type and characteristics of PDA and
      the chosen device, success and failure rates of the procedure, and adverse effects.

      The data is taken from patients' medical files - based on medical reports regarding physical
      examination, blood tests and imaging studies including cineangiograms and echo-doppler
      studies.
    


Study Type

Observational


Primary Outcome

Success of implantation

Secondary Outcome

 residual shunt

Condition

Patent Ductus Arteriosus



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

450

Start Date

January 1998

Completion Date

August 2013

Primary Completion Date

August 2013

Eligibility Criteria

        Inclusion Criteria:

          -  All the patients that underwent percutaneous closure of PDA between January 1998 and
             august 2013 in the department of pediatric cardiology and congenital heart diseases in
             Rambam health care campus

        Exclusion Criteria:

          -  None
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Moshe Dotan, MD, , 

Location Countries

Israel

Location Countries

Israel

Administrative Informations


NCT ID

NCT01929733

Organization ID

0192-13


Responsible Party

Sponsor

Study Sponsor

Rambam Health Care Campus


Study Sponsor

Moshe Dotan, MD, Principal Investigator, Rambam Health Care Campus


Verification Date

August 2013