Tetrology of FallotNCT03732742
Comparison of Mid-term Results of Total Correction of TOF Between Preservation of PV and Trans-annular Patch.
A study testing TOF repair with trans-annular patch VS preservation of PV in people with Tetrology of Fallot, run by Assiut University.
Trial summary
To compare of mid-term results of total correction of tetralogy of fallot between preservation of pulmonary valve and trans-annular patching , thus avoiding PV regurgitation during TOF repair , this will determine the value of this procedure over trans-annular patching regarding to right ventricular performance. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tetrology of Fallot
- What is being tested?
- TOF repair with trans-annular patch VS preservation of PV
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2018to Sep 2019
- Phase
- Interventional
- 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
Who may be able to join
- Patients undergoing elective total correction of tetralogy of Fallot.
- Any age group.
- Normal pulmonay branches
Who cannot join
- Patients associated with other congenital anomalies.
- Regarding PV morphology, patients with pulmonary atresia , absence of PV.
- Patients with anomalous coronary artery anatomy obstructs access to the RV
- Extra-cardiac illness that is expected to limit survival to less than 5 years.e.g active hepatitis or significant hepatic or renal disorders.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Mid-term Results of Total Correction of Tetralogy of Fallot Between Preservation of Pulmonary Valve and Trans-annular Patching
To compare of mid-term results of total correction of tetralogy of fallot between preservation of pulmonary valve and trans-annular patching , thus avoiding PV regurgitation during TOF repair , this will determine the value of this procedure over trans-annular patching regarding to right ventricular performance.
Read the detailed description
Surgical repair of congenital lesions associated with right ventricular outflow tract obstruction frequently requires the destruction of pulmonary valve (PV) competents including the pulmonary annulas. The resulatnt pulmonary insufficiency may lead to late functional deterioration of right ventricular performance. Acute right ventricular dysfunction has been associated with poor pulmonary runoff, tricuspid valve regurgitaion and pulmonary hypertension. Preservation of PV comptence may prevent both early and late right ventricular failure. Total repair of tetralogy of fallot is a corrective surgical procedure that involves closure of the ventricular septal defect (VSD) and relief of right ventricular outflow tract (RVOT) obstruction. The surgeon must decide whether the right ventricular outflow tract size will be sufficient to allow for the entire cardiac output to traverse it without causing extreme elevation in right ventricular pressure or will go for trans-annular patch. Recently interest has shifted to preserving the integrity of the pulmonary valve annulus thus avoiding pulmonary valve regurgitation.
- Conditions
- Tetrology of Fallot
- Being tested
- TOF repair with trans-annular patch VS preservation of PV
- Medical subject headings
- Tetralogy of Fallot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOF repair with trans-annular patch VS preservation of PVProcedure or surgery
One group study
| Study group | Role | What they receive |
|---|---|---|
| TOF repair with preservation of PV | Experimental | Surgical intervention by repair of Tetralogy of Fallot with preservation of pulmonary valve, recently interested has shifted to preserving the integrity of the pulmonary valve. Receives: Procedure: TOF repair with trans-annular patch VS preservation of PV |
| TOF repair with trans-annular patch | Experimental | Surgical intervention by repair of Tetralogy of Fallot with trans-annular patch, right ventricular hypertrophy, right ventricular dilatation and pulmonary vavle regurgitation has been recognized as one of the most important risk factors for both right and left ventricular performance after the repair of Tetralogy of Fallot. Receives: Procedure: TOF repair with trans-annular patch VS preservation of PV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gender
Parameters will be measured include gender preoperatively
Measured: One week for preoperative assessment.
Body weight
Parameters will be measured include body weight in kilograms preoperatively
Measured: One week for preoperative assessment.
Height
Parameters will be measured include height in meters preoperatively
Measured: One week for preoperative assessment.
Oxygen saturation , RV function
Parameters will be measured include Oxygen saturation level % , RV function by measure RV fractional area changes (RVFAC) % preoperatively
Measured: One week for preoperative assessment.
include median RVOT gradient and degree of PV stenosis
Parameters will be measured include median RVOT gradient in mmhg , degree of PV stenosis by peak gradient across the PV in mmhg preoperatively
Measured: One week for preoperative assessment.
PV annulus and PV z-score
Parameters will be measured include median PV annulus diameter in mm , median PV Z-score diameter in mm preoperatively
Measured: One week for preoperative assessment.
degree of PV regurge, degree of TR and RV size
Parameters will be measured include degree of PV regurge jet size by color doppler,degree of TR by jet area -central jets in cm^2 , RV size (RV diastolic area in cm^ , RV systolic area in cm^ ) preoperatively
Measured: One week for preoperative assessment.
Age
Parameters will be measured include age in months preoperatively
Measured: One week for preoperative assessment
Secondary outcomes (11)
Gender
Parameters will be measured include gender pre-discharge postoperative assessment.
Measured: Pre-discharge postoperative assessment within one month
Body weight
Parameters will be measured include body weight in kilograms pre-discharge postoperative assessment.
Measured: Pre-discharge postoperative assessment within one month
Height
Parameters will be measured include height in meters pre-discharge postoperative assessment.
Measured: Pre-discharge postoperative assessment within one month
Oxygen saturation , RV function
Parameters will be measured include Oxygen saturation level % , RV function by measure RV fractional area changes (RVFAC) % Pre-discharge postoperative assessment.
Measured: Pre-discharge postoperative assessment within one month
Median RVOT gradient and degree of PV stenosis
Parameters will be measured include median RVOT gradient in mmhg , degree of PV stenosis by peak gradient across the PV in mmhg pre-discharge postoperative assessment.
Measured: Pre-discharge postoperative assessment within one month
PV annulus and PV z-score
Parameters will be measured include median PV annulus diameter in mm , median PV Z-score diameter in mm pre-discharge postoperative assessment.
Measured: Pre-discharge postoperative assessment within one month
degree of PV regurge, degree of TR and RV size
Parameters will be measured include degree of PV regurge jet size by color doppler,degree of TR by jet area -central jets in cm^2 , RV size (RV diastolic area in cm^ , RV systolic area in cm^ ) pre-discharge postoperative assessment.
Measured: Pre-discharge postoperative assessment within one month
Median cross clamp time and CPB time
Parameters will be measured include Median cross clamp time in minutes and CPB time in minutes pre-discharge postoperative assessment.
Measured: Pre-discharge postoperative assessment within one month
ICU stay
Parameters will be measured include ICU stay days pre-discharge postoperative assessment.
Measured: Pre-discharge postoperative assessment within one month
Time till weaning from mechanical ventilator
Parameters will be measured include Time till weaning from mechanical ventilator in hours pre-discharge postoperative assessment.
Measured: Pre-discharge postoperative assessment within one month
Age
Parameters will be measured include age in months pre-discharge postoperative assessment.
Measured: Pre-discharge postoperative assessment within one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study startNov 2018 (estimated)
- Primary completionAug 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tetrology of FallotStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shareef aldesoky shareef, Assiut University
- Investigators
- Ahmed M. El-Minshawy, Prof, Study chair, Assiut UniversityMahmoud Kh Abdelatif, Ass.lecturer, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732742
- Sponsor's protocol ID
- TOF repair
- Status last verified
- Nov 2018
- First submitted
- 22 Oct 2018
- Last updated
- 7 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kwak JG, Kim WH, Kim ER, Lim JH, Min J. One-Year Follow-up After Tetralogy of Fallot Total Repair Preserving Pulmonary Valve and Avoiding Right Ventriculotomy. Circ J. 2018 Nov 24;82(12):3064-3068. doi: 10.1253/circj.CJ-18-0690. Epub 2018 Oct 5.
PubMed 30298850Vida VL, Angelini A, Guariento A, Frescura C, Fedrigo M, Padalino M, Sanders SP, Thiene G, Stellin G. Preserving the pulmonary valve during early repair of tetralogy of Fallot: Anatomic substrates and surgical strategies. J Thorac Cardiovasc Surg. 2015 May;149(5):1358-63.e1. doi: 10.1016/j.jtcvs.2015.01.030. Epub 2015 Jan 21.
PubMed 25983249
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Mid-term Results of Total Correction of Tetralogy of Fallot Between Preservation of Pulmonary Valve and Trans-annular Patching
- ClinicalTrials.gov ID
- NCT03732742
- Acronym / sponsor ID
- TOF repair
- Conditions
- Tetrology of Fallot
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2018 (estimated)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 7 Nov 2018 (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.
To compare of mid-term results of total correction of tetralogy of fallot between preservation of pulmonary valve and trans-annular patching , thus avoiding PV regurgitation during TOF repair , this will determine the value of this procedure over trans-annular patching regarding to right ventricular performance.
Detailed description
Surgical repair of congenital lesions associated with right ventricular outflow tract obstruction frequently requires the destruction of pulmonary valve (PV) competents including the pulmonary annulas. The resulatnt pulmonary insufficiency may lead to late functional deterioration of right ventricular performance. Acute right ventricular dysfunction has been associated with poor pulmonary runoff, tricuspid valve regurgitaion and pulmonary hypertension. Preservation of PV comptence may prevent both early and late right ventricular failure. Total repair of tetralogy of fallot is a corrective surgical procedure that involves closure of the ventricular septal defect (VSD) and relief of right ventricular outflow tract (RVOT) obstruction. The surgeon must decide whether the right ventricular outflow tract size will be sufficient to allow for the entire cardiac output to traverse it without causing extreme elevation in right ventricular pressure or will go for trans-annular patch. Recently interest has shifted to preserving the integrity of the pulmonary valve annulus thus avoiding pulmonary valve regurgitation.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TOF repair with preservation of PV | Experimental | Procedure: TOF repair with trans-annular patch VS preservation of PVSurgical intervention by repair of Tetralogy of Fallot with preservation of pulmonary valve, recently interested has shifted to preserving the integrity of the pulmonary valve. |
| TOF repair with trans-annular patch | Experimental | Procedure: TOF repair with trans-annular patch VS preservation of PVSurgical intervention by repair of Tetralogy of Fallot with trans-annular patch, right ventricular hypertrophy, right ventricular dilatation and pulmonary vavle regurgitation has been recognized as one of the most important risk factors for both right and left ventricular performance after the repair of Tetralogy of Fallot. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing elective total correction of tetralogy of Fallot.
- Any age group.
- Normal pulmonay branches
Key exclusion criteria (4 listed)
- Patients associated with other congenital anomalies.
- Regarding PV morphology, patients with pulmonary atresia , absence of PV.
- Patients with anomalous coronary artery anatomy obstructs access to the RV
- Extra-cardiac illness that is expected to limit survival to less than 5 years.e.g active hepatitis or significant hepatic or renal disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TOF repair with trans-annular patch VS preservation of PVOne group study | Procedure or surgery | TOF repair with preservation of PV, TOF repair with trans-annular patch |
Primary outcome
Gender
Time frame: One week for preoperative assessment.
Parameters will be measured include gender preoperatively
Body weight
Time frame: One week for preoperative assessment.
Parameters will be measured include body weight in kilograms preoperatively
Height
Time frame: One week for preoperative assessment.
Parameters will be measured include height in meters preoperatively
Oxygen saturation , RV function
Time frame: One week for preoperative assessment.
Parameters will be measured include Oxygen saturation level % , RV function by measure RV fractional area changes (RVFAC) % preoperatively
include median RVOT gradient and degree of PV stenosis
Time frame: One week for preoperative assessment.
Parameters will be measured include median RVOT gradient in mmhg , degree of PV stenosis by peak gradient across the PV in mmhg preoperatively
PV annulus and PV z-score
Time frame: One week for preoperative assessment.
Parameters will be measured include median PV annulus diameter in mm , median PV Z-score diameter in mm preoperatively
degree of PV regurge, degree of TR and RV size
Time frame: One week for preoperative assessment.
Parameters will be measured include degree of PV regurge jet size by color doppler,degree of TR by jet area -central jets in cm^2 , RV size (RV diastolic area in cm^ , RV systolic area in cm^ ) preoperatively
Age
Time frame: One week for preoperative assessment
Parameters will be measured include age in months preoperatively
11 secondary outcomes
Gender
Time frame: Pre-discharge postoperative assessment within one month
Body weight
Time frame: Pre-discharge postoperative assessment within one month
Height
Time frame: Pre-discharge postoperative assessment within one month
Oxygen saturation , RV function
Time frame: Pre-discharge postoperative assessment within one month
Median RVOT gradient and degree of PV stenosis
Time frame: Pre-discharge postoperative assessment within one month
PV annulus and PV z-score
Time frame: Pre-discharge postoperative assessment within one month
degree of PV regurge, degree of TR and RV size
Time frame: Pre-discharge postoperative assessment within one month
Median cross clamp time and CPB time
Time frame: Pre-discharge postoperative assessment within one month
ICU stay
Time frame: Pre-discharge postoperative assessment within one month
Time till weaning from mechanical ventilator
Time frame: Pre-discharge postoperative assessment within one month
Age
Time frame: Pre-discharge postoperative assessment within one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- Background: PubMed 30298850Kwak JG, Kim WH, Kim ER, Lim JH, Min J. One-Year Follow-up After Tetralogy of Fallot Total Repair Preserving Pulmonary Valve and Avoiding Right Ventriculotomy. Circ J. 2018 Nov 24;82(12):3064-3068. doi: 10.1253/circj.CJ-18-0690. Epub 2018 Oct 5.
- Background: PubMed 25983249Vida VL, Angelini A, Guariento A, Frescura C, Fedrigo M, Padalino M, Sanders SP, Thiene G, Stellin G. Preserving the pulmonary valve during early repair of tetralogy of Fallot: Anatomic substrates and surgical strategies. J Thorac Cardiovasc Surg. 2015 May;149(5):1358-63.e1. doi: 10.1016/j.jtcvs.2015.01.030. Epub 2015 Jan 21.
Related trials for Tetrology of Fallot
RecruitingPhase 4
Sodium-Glucose Cotransporter 2 Inhibitors for Repaired Tetralogy of Fallot Patients for Enhancement of Cardio-Pulmonary Status Trial
Congenital Heart Disease, Repaired Tetralogy of Fallot (rTOF)
RecruitingPhase 1
Beta-blocker Administration for Cardiomyocyte Division
Tetralogy of Fallot, Double Outlet Right Ventricle
Active, not recruiting
ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR)
Recruiting
Investigation of Tetralogy of Fallot in Neonates
Tetralogy of Fallot (TOF), Pulmonary Stenosis
RecruitingObservational study
Volution of Pulmonary Artery Dimensions in Tetralogy of Fallot
Tetralogy of Fallot (TOF), Congenital Heart Defects
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.
Ahmed M. El-Minshawy, Prof study chair
Assiut University
Mahmoud Kh Abdelatif, Ass.lecturer study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing TOF repair with trans-annular patch VS preservation of PV in people with Tetrology of Fallot, 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 3 inclusion and 4 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 7 Nov 2018. 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?
Contact Shareef Al Shareef, Master (+966533505988, shareefaldesoky12@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gender (time frame: One week for preoperative assessment.). The study lists 8 primary outcomes in all. 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 NCT03732742, which also lists 2 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 7 Nov 2018.