Cardiac CatheterizationNCT06134141
The Outcome of Interventional Cardiac Catheterization In Pediatric Cardiology Unit, Assiut University Heart Hospital
An observational study of Cardiac Catheterization, run by Assiut University.
Trial summary
Describe demographic and clinical data of infant and pediatric with cardiac catheterization who admitted to cardiology unit of Assiut university children hospital Asses outcome of cardiac catheterization in pediatric and infant at AUCH Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Cardiac Catheterization
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 17 Nov 2023to 31 Mar 2025
- 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 1 month to 18 years
- All sexes
- Child, Adult
Study population: children aged 1 month to 18 years old that underwent cardiac catheterization for congenital heart disease management.
Who may be able to join
- children aged 1 month to 18 years old that underwent cardiac catheterization for congenital heart disease management.
- -
Who cannot join
- 1-Neonate aged less than 1 month and adult >16 years old 2-Patients with chronic renal and hepatic disease could affect results
- -
About this study
Describe demographic and clinical data of infant and pediatric with cardiac catheterization who admitted to cardiology unit of Assiut university children hospital Asses outcome of cardiac catheterization in pediatric and infant at AUCH
Read the detailed description
Cardiac catheterization and intervention in pediatric cardiac diseases have evolved significantly in the past 30 years. During the last 10 years, there have been major technological achievements in pediatric interventional cardiology There have also been substantial advancements in cardiac imaging modalities, such as intracardiac echocardiography (ICE), real-time 3-dimensional (3D) transesophageal echocardiography (TEE), cardiac computed tomography (CT) and magnetic resonance imaging (MRI), rotational angiography with 3D roadmap, holography, 3D printing, and Echo-Navigator and Vessel-Navigator systems. As a result of such technological advances, more types of congenital heart diseases (CHDs) can be treated in the cardiac catheter laboratory today than ever before. Therefore, the possibility exists that many surgical procedures will be replaced by catheter-based procedures
The pediatric interventional cardiology community has continued to develop less invasive solutions for congenital heart defects (CHDs) to minimize the need for open heart surgery and optimize overall outcomes. Many CHDs are effectively managed with transcatheter techniques. Atrial and ventricular septal defects, valve stenosis, patent ductus arteriosus, aortic coarctation, pulmonary artery and vein stenosis and arteriovenous malformations are some examples, routinely treated with catheterization in the pediatric population For most such interventions, these efforts lead to more highly acceptable outcomes and lower complication rates than the alternatives of surgery or no intervention
- Conditions
- Cardiac Catheterization
What is being measured
The primary outcome is the main question the study is designed to answer.
procedure time [ Time Frame: duration of the cardiac catheterization procedure (1-4 hours depending on complexity of case) ]
duration of the cardiac catheterization procedure (1-4 hours depending on complexity of case|)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start17 Nov 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiac CatheterizationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya zidan sayed gomaa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134141
- Sponsor's protocol ID
- CC OUTCOME
- Status last verified
- Nov 2023
- First submitted
- 6 Nov 2023
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Crystal MA, Ing FF. Pediatric interventional cardiology: 2009. Curr Opin Pediatr. 2010 Oct;22(5):567-72. doi: 10.1097/MOP.0b013e32833e1328.
PubMed 20733492Moustafa GA, Kolokythas A, Charitakis K, Avgerinos DV. Therapeutic Utilities of Pediatric Cardiac Catheterization. Curr Cardiol Rev. 2016;12(4):258-269. doi: 10.2174/1573403x12666160301121253.
PubMed 26926291Backes CH, Cheatham SL, Deyo GM, Leopold S, Ball MK, Smith CV, Garg V, Holzer RJ, Cheatham JP, Berman DP. Percutaneous Patent Ductus Arteriosus (PDA) Closure in Very Preterm Infants: Feasibility and Complications. J Am Heart Assoc. 2016 Feb 12;5(2):e002923. doi: 10.1161/JAHA.115.002923.
PubMed 26873689
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Outcome of Interventional Cardiac Catheterization In Pediatric Cardiology Unit, Assiut University Heart Hospital
- ClinicalTrials.gov ID
- NCT06134141
- Acronym / sponsor ID
- CC OUTCOME
- Conditions
- Cardiac Catheterization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 17 Nov 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 18 Nov 2023 (actual)
- 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.
Describe demographic and clinical data of infant and pediatric with cardiac catheterization who admitted to cardiology unit of Assiut university children hospital Asses outcome of cardiac catheterization in pediatric and infant at AUCH
Detailed description
Cardiac catheterization and intervention in pediatric cardiac diseases have evolved significantly in the past 30 years. During the last 10 years, there have been major technological achievements in pediatric interventional cardiology There have also been substantial advancements in cardiac imaging modalities, such as intracardiac echocardiography (ICE), real-time 3-dimensional (3D) transesophageal echocardiography (TEE), cardiac computed tomography (CT) and magnetic resonance imaging (MRI), rotational angiography with 3D roadmap, holography, 3D printing, and Echo-Navigator and Vessel-Navigator systems. As a result of such technological advances, more types of congenital heart diseases (CHDs) can be treated in the cardiac catheter laboratory today than ever before. Therefore, the possibility exists that many surgical procedures will be replaced by catheter-based procedures
The pediatric interventional cardiology community has continued to develop less invasive solutions for congenital heart defects (CHDs) to minimize the need for open heart surgery and optimize overall outcomes. Many CHDs are effectively managed with transcatheter techniques. Atrial and ventricular septal defects, valve stenosis, patent ductus arteriosus, aortic coarctation, pulmonary artery and vein stenosis and arteriovenous malformations are some examples, routinely treated with catheterization in the pediatric population For most such interventions, these efforts lead to more highly acceptable outcomes and lower complication rates than the alternatives of surgery or no intervention
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- children aged 1 month to 18 years old that underwent cardiac catheterization for congenital heart disease management.
Key inclusion criteria (2 listed)
- children aged 1 month to 18 years old that underwent cardiac catheterization for congenital heart disease management.
- -
Key exclusion criteria (2 listed)
- 1-Neonate aged less than 1 month and adult >16 years old 2-Patients with chronic renal and hepatic disease could affect results
- -
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
procedure time [ Time Frame: duration of the cardiac catheterization procedure (1-4 hours depending on complexity of case) ]
Time frame: Baseline
duration of the cardiac catheterization procedure (1-4 hours depending on complexity of case|)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Background: PubMed 20733492Crystal MA, Ing FF. Pediatric interventional cardiology: 2009. Curr Opin Pediatr. 2010 Oct;22(5):567-72. doi: 10.1097/MOP.0b013e32833e1328.
- Background: PubMed 26926291Moustafa GA, Kolokythas A, Charitakis K, Avgerinos DV. Therapeutic Utilities of Pediatric Cardiac Catheterization. Curr Cardiol Rev. 2016;12(4):258-269. doi: 10.2174/1573403x12666160301121253.
- Background: PubMed 26873689Backes CH, Cheatham SL, Deyo GM, Leopold S, Ball MK, Smith CV, Garg V, Holzer RJ, Cheatham JP, Berman DP. Percutaneous Patent Ductus Arteriosus (PDA) Closure in Very Preterm Infants: Feasibility and Complications. J Am Heart Assoc. 2016 Feb 12;5(2):e002923. doi: 10.1161/JAHA.115.002923.
Related trials for Cardiac Catheterization
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Not yet recruiting
Novel Wearable Device for Heart Failure Management
Heart Failure
RecruitingPhase 4
Propofol-Ketamine Versus Sevoflurane for Laryngeal Mask Anesthesia in Pediatric Cardiac Catheterization
Propofol, Ketamine
RecruitingObservational study
Comparison of Cardiac Index Measurement Using Right Ventricular Pressure Curve Analysis and Thermodilution Via a Swan-Ganz IQ™ Catheter.
Septic Shock
RecruitingObservational study
Artificial Intelligence-assisted Evaluation of Pulmonary HYpertension
Pulmonary Hypertension, Pulmonary Arterial Hypertension
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Catheterization, run by Assiut University.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
procedure time [ Time Frame: duration of the cardiac catheterization procedure (1-4 hours depending on complexity of case) ] (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06134141, which also lists 3 linked publications.
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 22 Nov 2023.