Patent Ductus ArteriosusNCT01929733
Long Term Results of 450 Percutaneous Closures of PDA in a Single Center
An observational study of Patent Ductus Arteriosus, run by Rambam Health Care Campus at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patent Ductus Arteriosus
- How many people
- 450 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 1998to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Patent Ductus Arteriosus
- Keywords
- Patent Ductus Arteriosus
- Medical subject headings
- Ductus Arteriosus, Patent
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of implantation
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.
Measured: one day, 10 days and a year after PDA closure and then last check-up exam
Secondary outcomes (1)
residual shunt
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.
Measured: one day, 10 days and a year after PDA closure and then last check-up exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2013 (estimated)
- Study startJan 1998
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patent Ductus ArteriosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moshe Dotan, MD, Principal investigator, Rambam Health Care CampusOmer Ephrat, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01929733
- Sponsor's protocol ID
- 0192-13
- Status last verified
- Aug 2013
- First submitted
- 14 Aug 2013
- Last updated
- 28 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Results of 450 Percutaneous Closures of PDA in a Single Center
- ClinicalTrials.gov ID
- NCT01929733
- Acronym / sponsor ID
- 0192-13
- Conditions
- Patent Ductus Arteriosus
- Keywords
- Patent Ductus Arteriosus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jan 1998
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 28 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
residual shunt
Time frame: one day, 10 days and a year after PDA closure and then last check-up exam
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moshe Dotan, MD principal investigator
Rambam Health Care Campus
Omer Ephrat principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patent Ductus Arteriosus, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of implantation (time frame: one day, 10 days and a year after PDA closure and then last check-up exam). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2013.