Comparison of Mid-term Results of Total Correction of TOF Between Preservation of PV and Trans-annular Patch.

Tetrology of Fallot Clinical Trial

Official title:

Comparison of Mid-term Results of Total Correction of Tetralogy of Fallot Between Preservation of Pulmonary Valve and Trans-annular Patching

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03732742
• Other study ID #: TOF repair
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2018
• Est. completion date: September 2019

Study information

• Verified date: November 2018
• Source: Assiut University
• Contact: Shareef Al Shareef, Master
• Phone: +966533505988
• Email: shareefaldesoky12[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Patients undergoing elective total correction of tetralogy of Fallot.

2. Any age group.

3. Normal pulmonay branches

Exclusion Criteria:

1. Patients associated with other congenital anomalies.

2. Regarding PV morphology, patients with pulmonary atresia , absence of PV.

3. Patients with anomalous coronary artery anatomy obstructs access to the RV

4. Extra-cardiac illness that is expected to limit survival to less than 5 years.e.g active hepatitis or significant hepatic or renal disorders.

Related Conditions & MeSH terms

• Tetralogy of Fallot
• Tetrology of Fallot

Intervention

Procedure:
• TOF repair with trans-annular patch VS preservation of PV
One group study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

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 Oct 5. doi: 10.1253/circj.CJ-18-0690. [Epub ahead of print] — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gender	Parameters will be measured include gender in follow up after 6 months.	Reassessment after 6 months.
Other	Body weight	Parameters will be measured include body weight in kilograms in follow up after 6 months.	Reassessment after 6 months.
Other	Height	Parameters will be measured include body height in meters in follow up after 6 months.	Reassessment after 6 months.
Other	Oxygen saturation , RV function	Parameters will be measured include Oxygen saturation level % , RV function by measure RV fractional area changes (RVFAC) % in follow up after 6 months.	Reassessment after 6 months.
Other	include median RVOT gradient and degree of PV stenosis	Parameters will be measured include include median RVOT gradient in mmhg and degree of PV stenosis by peak gradient across the PV in mmhg in follow up after 6 months.	Reassessment after 6 months.
Other	PV annulus and PV z-score	Parameters will be measured include median PV annulus diameter in mm , median PV Z-score diameter in mm in follow up after 6 months.	Reassessment after 6 months.
Other	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^ ) in follow up after 6 months.	Reassessment after 6 months.
Other	Age	Parameters will be measured include age in months in follow up after 6 months.	Reassessment after 6 months.
Primary	Gender	Parameters will be measured include gender preoperatively	One week for preoperative assessment.
Primary	Body weight	Parameters will be measured include body weight in kilograms preoperatively	One week for preoperative assessment.
Primary	Height	Parameters will be measured include height in meters preoperatively	One week for preoperative assessment.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	Age	Parameters will be measured include age in months preoperatively	One week for preoperative assessment
Secondary	Gender	Parameters will be measured include gender pre-discharge postoperative assessment.	Pre-discharge postoperative assessment within one month
Secondary	Body weight	Parameters will be measured include body weight in kilograms pre-discharge postoperative assessment.	Pre-discharge postoperative assessment within one month
Secondary	Height	Parameters will be measured include height in meters pre-discharge postoperative assessment.	Pre-discharge postoperative assessment within one month
Secondary	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.	Pre-discharge postoperative assessment within one month
Secondary	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.	Pre-discharge postoperative assessment within one month
Secondary	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.	Pre-discharge postoperative assessment within one month
Secondary	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.	Pre-discharge postoperative assessment within one month
Secondary	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.	Pre-discharge postoperative assessment within one month
Secondary	ICU stay	Parameters will be measured include ICU stay days pre-discharge postoperative assessment.	Pre-discharge postoperative assessment within one month
Secondary	Time till weaning from mechanical ventilator	Parameters will be measured include Time till weaning from mechanical ventilator in hours pre-discharge postoperative assessment.	Pre-discharge postoperative assessment within one month
Secondary	Age	Parameters will be measured include age in months pre-discharge postoperative assessment.	Pre-discharge postoperative assessment within one month