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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
National Cardiovascular Center Harapan Kita Hospital Indonesia
About
Eligibility
Locations
Arms
Outcomes
Full info

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

1 Month - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with mitral regurgitation heart disease.
  2. Patients with an age range of 1 day - 18 years
  3. Patients with mitral regurgitation heart disease with atrial septal defects
  4. Mitral valve repair surgery performed by single surgeon (Budi Rahmat, MD)

Exclusion Criteria:

  1. Patients refuse to participate in the study.
  2. Having additional cardiac abnormalities other than atrial septal defects that change the surgery plan.
  3. Reoperation mitral valve surgery.
  4. History of abnormalities in the central nervous system / preoperative stroke.
  5. Patients with severe pulmonary hypertension
  6. Patients with small left ventricles (LV smallish)
  7. History of pulmonary resuscitation (CPR) before surgery.

Dropout Criteria

  1. The patient fails to complete the entire examination procedure.
  2. Mitral regurgitation patients who are decided to do mitral valve replacement intra-operatively.
  3. Using extracorporeal life support (ECMO) device after surgery.
  4. 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

    First Posted
    August 2, 2020
    Last Updated
    August 16, 2020
    Sponsor
    National Cardiovascular Center Harapan Kita Hospital Indonesia
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    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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