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

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ClinicalTrials.gov Identifier: NCT01929733
Recruitment Status : Completed
First Posted : August 28, 2013
Last Update Posted : August 28, 2013
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus

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.


Condition or disease
Patent Ductus Arteriosus

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.

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Study Type : Observational
Actual Enrollment : 450 participants
Time Perspective: Retrospective
Official Title: Long Term Results of 450 Percutaneous Closures of PDA in a Single Center
Study Start Date : January 1998
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Success of implantation [ Time Frame: one day, 10 days and a year after PDA closure and then last check-up exam ]
    due to the fact that the research is retrospective and refers to a period of 15 years (1998-2013)and the fact that some patients had a check-up exam from time to time - the investigators have decided to include in this research the last check-up exam as well.


Secondary Outcome Measures :
  1. residual shunt [ Time Frame: one day, 10 days and a year after PDA closure and then last check-up exam ]
    due to the fact that the research is retrospective and refers to a period of 15 years (1998-2013) and the fact that some patients had a check-up exam from time to time - the investigators have decided to include in this research the last check-up exam as well.


Other Outcome Measures:
  1. Early and late Adverse effects [ Time Frame: one day, 10 days and a year after PDA closure and then last check-up exam ]
    hemolysis, bleeding, infections ect. due to the fact that the research is retrospective and refers to a period of 15 years (1998-2013)and the fact that some patients had a check-up exam from time to time - the investigators have decided to include in this research the last check-up exam as well.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929733


Locations
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Israel
RAMBAM health care center
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: Moshe Dotan, MD Rambam Health Care Campus
Principal Investigator: Omer Ephrat Rambam Health Care Campus
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Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01929733    
Other Study ID Numbers: 0192-13
First Posted: August 28, 2013    Key Record Dates
Last Update Posted: August 28, 2013
Last Verified: August 2013
Keywords provided by Rambam Health Care Campus:
Patent Ductus Arteriosus
Additional relevant MeSH terms:
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Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities