NCT03732742|Unknown
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Sponsor study identifier
interventional
50
0 countries
N/A
Study Start
November 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
August 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 22, 2018
Actual (reported)November 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 7, 2018
Actual (reported)August 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Gender
Parameters will be measured include gender preoperatively
One week for preoperative assessment.
Body weight
Parameters will be measured include body weight in kilograms preoperatively
One week for preoperative assessment.
Height
Parameters will be measured include height in meters preoperatively
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
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
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
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
One week for preoperative assessment.
Age
Parameters will be measured include age in months preoperatively
One week for preoperative assessment
Gender
Pre-discharge postoperative assessment within one month
Body weight
Pre-discharge postoperative assessment within one month
Height
Pre-discharge postoperative assessment within one month
Oxygen saturation , RV function
Pre-discharge postoperative assessment within one month
Median RVOT gradient and degree of PV stenosis
Pre-discharge postoperative assessment within one month
Gender
Reassessment after 6 months.
Body weight
Reassessment after 6 months.
Height
Reassessment after 6 months.
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.
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.
One group study
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Vida 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.
Ahmed M. El-Minshawy, Prof
Assiut University
Mahmoud Kh Abdelatif, Ass.lecturer
Assiut University
First Submitted
October 22, 2018
First Posted
November 7, 2018
Study Start
November 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Understanding Dexmedetomidine in Neonates After Open Heart Surgery
Contact the study team to confirm eligibility.
August 2019
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 7, 2018
Record last verified: 2018-11
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Source: ClinicalTrials.gov.
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