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

Completed

• Conditions: Patent Ductus Arteriosus

• Registration Number: NCT01929733
• Lead Sponsor: 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.

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 Timeline

• Study Start: 1998-01
• Status Verified: 2013-08
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Study First Submitted: 2013-08-14
• Study First Submitted QC: 2013-08-21
• Last Update Submitted: 2013-08-21
• Study First Posted: 2013-08-28
• Last Update Posted: 2013-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Success of implantation	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

Name	Time	Method
residual shunt	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.

Trial Locations

Locations (1)

RAMBAM health care center; 🇮🇱 Haifa, Israel