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

NCT ID: NCT01929733

Last Updated: 2013-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

1998-01-31

Study Completion Date

2013-08-31

Brief Summary

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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

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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.

Conditions

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Patent Ductus Arteriosus

Keywords

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Patent Ductus Arteriosus

Study Design

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Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Moshe Dotan, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Omer Ephrat

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

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RAMBAM health care center

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0192-13

Identifier Type: -

Identifier Source: org_study_id