Ignite Creation Date:
2024-05-06 @ 3:04 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04518709
Status:
UNKNOWN
Last Update Posted:
2020-08-19
First Post:
2020-08-02
Brief Title:
The Effect of Posterior Annulus Elevation Technique in Reducing Residual Regurgitation During Mitral Valve Repair in Children
Sponsor:
National Cardiovascular Center Harapan Kita Hospital Indonesia
Organization:
National Cardiovascular Center Harapan Kita Hospital Indonesia
Study Overview
Official Title:
The Effect of Posterior Annulus Elevation Technique in Reducing Residual Regurgitation During Mitral Valve Repair in Children
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main problem in mitral valve repair surgery in children is the high number of postoperative residual lesions 49 of the total cases Residual lesions after mitral valve repair are associated with morbidity and complications in the form of hemolysis and could affect the postoperative reverse remodeling process Surgery techniques for mitral valve repair in children have fewer choices than adult patients because of the smaller and thinner valve structure Besides the weakness of the mitral valve repair technique that often occurs in large left ventricles with severe mitral regurgitation after repairing with ring annuloplasty there is usually a mild residual regurgitation due to posterior mitral leaflet that tends to become restrictive due to being attracted by the left ventricular wall that remains big No technique has been found to overcome the problem of mitral regurgitation residuals that occur postoperatively Therefore by analyzing postoperative mitral valve structural abnormalities with conventional techniques an additional posterior mitral valve elevation technique was designed to increase the area of coaptation between two leaves of the mitral valve so that the incidence of postoperative regurgitation lesions can be reduced
Detailed Description:
The main problem in mitral valve repair surgery in children is the high number of postoperative residual lesions 49 of the total cases Residual lesions after mitral valve repair are associated with morbidity and complications in the form of hemolysis and could affect the postoperative reverse remodeling process Surgery techniques for mitral valve repair in children have fewer choices than adult patients because of the smaller and thinner valve structure Besides the weakness of the mitral valve repair technique that often occurs in large left ventricles with severe mitral regurgitation after repairing with ring annuloplasty there is usually a mild residual regurgitation due to posterior mitral leaflet that tends to become restrictive due to being attracted by the left ventricular wall that remains big No technique has been found to overcome the problem of mitral regurgitation residuals that occur postoperatively
Therefore by analyzing postoperative mitral valve structural abnormalities with conventional techniques an additional posterior mitral valve elevation technique was designed The posterior annulus elevation technique is a technique that is carried by lifting the posterior mitral annulus towards the cranial so that the posterior mitral leaflet can meet perfectly with the anterior mitral leaflet indicated by a larger coaptation area This technique can be applied after repair with conventional techniques done optimally to reduce the possibility of postoperative residual lesions
The hypothesis in this study is that pediatric patients with mitral regurgitation who undergo mitral valve repair surgery with posterior annulus elevation techniques can reduce residual mitral regurgitation improve clinical and metabolic outcomes of postoperative heart failure and reduce the risk of postoperative hemolysis
Therefore by analyzing postoperative mitral valve structural abnormalities with conventional techniques an additional posterior mitral valve elevation technique was designed The posterior annulus elevation technique is a technique that is carried by lifting the posterior mitral annulus towards the cranial so that the posterior mitral leaflet can meet perfectly with the anterior mitral leaflet indicated by a larger coaptation area This technique can be applied after repair with conventional techniques done optimally to reduce the possibility of postoperative residual lesions
The hypothesis in this study is that pediatric patients with mitral regurgitation who undergo mitral valve repair surgery with posterior annulus elevation techniques can reduce residual mitral regurgitation improve clinical and metabolic outcomes of postoperative heart failure and reduce the risk of postoperative hemolysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None