The Effect of Posterior Annulus Elevation Technique in Reducing Residual Regurgitation During Mitral Valve Repair in Children
Primary Purpose
Mitral Valve Insufficiency
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Posterior Mitral Annulus Elevation Technique
Conventional Mitral Valve Repair
Sponsored by
About this trial
This is an interventional treatment trial for Mitral Valve Insufficiency focused on measuring Posterior Annulus Elevation Technique, Pediatric Mitral Valve Insufficiency
Eligibility Criteria
Inclusion Criteria:
- Patients with mitral regurgitation heart disease.
- Patients with an age range of 1 day - 18 years
- Patients with mitral regurgitation heart disease with atrial septal defects
- Mitral valve repair surgery performed by single surgeon (Budi Rahmat, MD)
Exclusion Criteria:
- Patients refuse to participate in the study.
- Having additional cardiac abnormalities other than atrial septal defects that change the surgery plan.
- Reoperation mitral valve surgery.
- History of abnormalities in the central nervous system / preoperative stroke.
- Patients with severe pulmonary hypertension
- Patients with small left ventricles (LV smallish)
- History of pulmonary resuscitation (CPR) before surgery.
Dropout Criteria
- The patient fails to complete the entire examination procedure.
- Mitral regurgitation patients who are decided to do mitral valve replacement intra-operatively.
- Using extracorporeal life support (ECMO) device after surgery.
- History of intra-operative CPR.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Posterior Annulus Elevation Technique Group
Without Posterior Annulus Elevation Technique Group
Arm Description
In patients who were determined in the treatment group, after the conventional procedure for mitral valve repair was completed, a posterior mitral valve elevation technique will be performed.
No additional procedure will be done after conventional mitral valve repair
Outcomes
Primary Outcome Measures
Residual mitral valve regurgitation
Residual mitral valve regurgitation is measured using transesophageal echocardiography and transthoracic echocardiography
Mitral valve coaptation area
Mitral valve coaptation area is measured using transesophageal echocardiography and transthoracic echocardiography
Change of Haptoglobin at 3 months after surgery
Serum haptoglobin level that indicated the presence of intravascular hemolysis is measured after the surgery
Change of Lactate dehydrogenase at 3 months after surgery
Lactate dehydrogenase level that indicated the presence of intravascular hemolysis is measured after the surgery
Change of NT-proBNP at 3 months after surgery
NTproBNP is a marker of acute heart failure and indicates the process of heart remodeling.
Secondary Outcome Measures
Full Information
NCT ID
NCT04518709
First Posted
August 2, 2020
Last Updated
August 16, 2020
Sponsor
National Cardiovascular Center Harapan Kita Hospital Indonesia
1. Study Identification
Unique Protocol Identification Number
NCT04518709
Brief Title
The Effect of Posterior Annulus Elevation Technique in Reducing Residual Regurgitation During Mitral Valve Repair in Children
Official Title
The Effect of Posterior Annulus Elevation Technique in Reducing Residual Regurgitation During Mitral Valve Repair in Children
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 17, 2020 (Anticipated)
Primary Completion Date
August 17, 2022 (Anticipated)
Study Completion Date
August 17, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cardiovascular Center Harapan Kita Hospital Indonesia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Insufficiency
Keywords
Posterior Annulus Elevation Technique, Pediatric Mitral Valve Insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Posterior Annulus Elevation Technique Group
Arm Type
Experimental
Arm Description
In patients who were determined in the treatment group, after the conventional procedure for mitral valve repair was completed, a posterior mitral valve elevation technique will be performed.
Arm Title
Without Posterior Annulus Elevation Technique Group
Arm Type
Placebo Comparator
Arm Description
No additional procedure will be done after conventional mitral valve repair
Intervention Type
Procedure
Intervention Name(s)
Posterior Mitral Annulus Elevation Technique
Intervention Description
Posterior mitral annulus elevation technique is performed using a large pledget and non-absorbable braided suture starting from the subvalvular section of the posterior mitral valve sutured to the ring annuloplasty (if in the process of repairing the mitral valve, ring implantation is performed; if without the use of ring annuloplasty, the suture is placed in the left atrial wall / supravalvular of PML), so that the posterior annulus is slightly attracted upward toward the cranial and the PML moves toward the center.
Intervention Type
Procedure
Intervention Name(s)
Conventional Mitral Valve Repair
Intervention Description
Conventional mitral valve repair in the pediatric patient using annuloplasty, leaflet resection and plication, sliding-plasty of chordae technique
Primary Outcome Measure Information:
Title
Residual mitral valve regurgitation
Description
Residual mitral valve regurgitation is measured using transesophageal echocardiography and transthoracic echocardiography
Time Frame
5 days after surgery
Title
Mitral valve coaptation area
Description
Mitral valve coaptation area is measured using transesophageal echocardiography and transthoracic echocardiography
Time Frame
Intraoperative
Title
Change of Haptoglobin at 3 months after surgery
Description
Serum haptoglobin level that indicated the presence of intravascular hemolysis is measured after the surgery
Time Frame
Preoperative (baseline), 5 days, 2 weeks and 3 months after surgery
Title
Change of Lactate dehydrogenase at 3 months after surgery
Description
Lactate dehydrogenase level that indicated the presence of intravascular hemolysis is measured after the surgery
Time Frame
Preoperative (baseline), 5 days, 2 weeks and 3 months after surgery
Title
Change of NT-proBNP at 3 months after surgery
Description
NTproBNP is a marker of acute heart failure and indicates the process of heart remodeling.
Time Frame
Preoperative (baseline), 5 days, 2 weeks and 3 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with mitral regurgitation heart disease.
Patients with an age range of 1 day - 18 years
Patients with mitral regurgitation heart disease with atrial septal defects
Mitral valve repair surgery performed by single surgeon (Budi Rahmat, MD)
Exclusion Criteria:
Patients refuse to participate in the study.
Having additional cardiac abnormalities other than atrial septal defects that change the surgery plan.
Reoperation mitral valve surgery.
History of abnormalities in the central nervous system / preoperative stroke.
Patients with severe pulmonary hypertension
Patients with small left ventricles (LV smallish)
History of pulmonary resuscitation (CPR) before surgery.
Dropout Criteria
The patient fails to complete the entire examination procedure.
Mitral regurgitation patients who are decided to do mitral valve replacement intra-operatively.
Using extracorporeal life support (ECMO) device after surgery.
History of intra-operative CPR.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Budi Rahmat, MD
Phone
+628128800076
Email
budirahmat@gmail.com
12. IPD Sharing Statement
Learn more about this trial
The Effect of Posterior Annulus Elevation Technique in Reducing Residual Regurgitation During Mitral Valve Repair in Children
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