Mitral Valve InsufficiencyNCT04518709
The Effect of Posterior Annulus Elevation Technique in Reducing Residual Regurgitation During Mitral Valve Repair in Children
A study testing Posterior Mitral Annulus Elevation Technique and Conventional Mitral Valve Repair in people with Mitral Valve Insufficiency, run by National Cardiovascular Center Harapan Kita Hospital Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Mitral Valve Insufficiency
- What is being tested?
- Posterior Mitral Annulus Elevation Technique and Conventional Mitral Valve Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 17 Aug 2020to 17 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 12Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Mitral Valve Insufficiency
- Being tested
- Posterior Mitral Annulus Elevation Technique, Conventional Mitral Valve Repair
- Keywords
- Posterior Annulus Elevation Technique, Pediatric Mitral Valve Insufficiency
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior Mitral Annulus Elevation TechniqueProcedure or surgery
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.
Conventional Mitral Valve RepairProcedure or surgery
Conventional mitral valve repair in the pediatric patient using annuloplasty, leaflet resection and plication, sliding-plasty of chordae technique
| Study group | Role | What they receive |
|---|---|---|
| Posterior Annulus Elevation Technique Group | Experimental | 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. Receives: Procedure: Posterior Mitral Annulus Elevation Technique |
| Without Posterior Annulus Elevation Technique Group | Placebo comparator | No additional procedure will be done after conventional mitral valve repair Receives: Procedure: Conventional Mitral Valve Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual mitral valve regurgitation
Residual mitral valve regurgitation is measured using transesophageal echocardiography and transthoracic echocardiography
Measured: 5 days after surgery
Mitral valve coaptation area
Mitral valve coaptation area is measured using transesophageal echocardiography and transthoracic echocardiography
Measured: Intraoperative
Change of Haptoglobin at 3 months after surgery
Serum haptoglobin level that indicated the presence of intravascular hemolysis is measured after the surgery
Measured: Preoperative (baseline), 5 days, 2 weeks and 3 months after 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
Measured: Preoperative (baseline), 5 days, 2 weeks and 3 months after 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.
Measured: Preoperative (baseline), 5 days, 2 weeks and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start17 Aug 2020 (estimated)
- Primary completion17 Aug 2022 (estimated)
- Study completion17 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cardiovascular Center Harapan Kita Hospital Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Budi Rahmat, National Cardiovascular Center Harapan Kita Hospital Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518709
- Sponsor's protocol ID
- NationalCCHK
- Status last verified
- Aug 2020
- First submitted
- 2 Aug 2020
- Last updated
- 19 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Posterior Annulus Elevation Technique in Reducing Residual Regurgitation During Mitral Valve Repair in Children
- ClinicalTrials.gov ID
- NCT04518709
- Acronym / sponsor ID
- NationalCCHK
- Conditions
- Mitral Valve Insufficiency
- Keywords
- Posterior Annulus Elevation Technique, Pediatric Mitral Valve Insufficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- National Cardiovascular Center Harapan Kita Hospital IndonesiaUniversity, hospital or other
- Study start
- 17 Aug 2020 (estimated)
- Primary completion
- 17 Aug 2022 (estimated)
- Study completion
- 17 Aug 2022 (estimated)
- First posted
- 19 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posterior Annulus Elevation Technique Group | Experimental | Procedure: Posterior Mitral Annulus Elevation TechniqueIn 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. |
| Without Posterior Annulus Elevation Technique Group | Placebo comparator | Procedure: Conventional Mitral Valve RepairNo additional procedure will be done after conventional mitral valve repair |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posterior Mitral Annulus Elevation TechniquePosterior 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. | Procedure or surgery | Posterior Annulus Elevation Technique Group |
| Conventional Mitral Valve RepairConventional mitral valve repair in the pediatric patient using annuloplasty, leaflet resection and plication, sliding-plasty of chordae technique | Procedure or surgery | Without Posterior Annulus Elevation Technique Group |
Primary outcome
Residual mitral valve regurgitation
Time frame: 5 days after surgery
Residual mitral valve regurgitation is measured using transesophageal echocardiography and transthoracic echocardiography
Mitral valve coaptation area
Time frame: Intraoperative
Mitral valve coaptation area is measured using transesophageal echocardiography and transthoracic echocardiography
Change of Haptoglobin at 3 months after surgery
Time frame: Preoperative (baseline), 5 days, 2 weeks and 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
Time frame: Preoperative (baseline), 5 days, 2 weeks and 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
Time frame: Preoperative (baseline), 5 days, 2 weeks and 3 months after surgery
NTproBNP is a marker of acute heart failure and indicates the process of heart remodeling.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Posterior Mitral Annulus Elevation Technique and Conventional Mitral Valve Repair in people with Mitral Valve Insufficiency, run by National Cardiovascular Center Harapan Kita Hospital Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Budi Rahmat, MD (+628128800076, budirahmat@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residual mitral valve regurgitation (time frame: 5 days after surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2020.