Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-31 @ 9:33 PM
Study NCT ID:
NCT01929733
Status:
COMPLETED
Last Update Posted:
2013-08-28
First Post:
2013-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Term Results of 450 Percutaneous Closures of PDA in a Single Center
Sponsor:
Rambam Health Care Campus
Organization:
Study Overview
Official Title:
Long Term Results of 450 Percutaneous Closures of PDA in a Single Center
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: