Ring Versus Suture Annuloplasty For Functional Tricuspid Regurgitation In Rheumatic Mitral Valve Diseases

Study Overview
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Brief Summary
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This study aims to compare whether De Vega's Suture annuloplasty is equally effective in reducing the progression of Functional Tricuspid regurgitation as that claimed for Ring annuloplasty in Rheumatic Heart Disease patients with concurrent Mitral valve replacement.

Detailed Description
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Functional Tricuspid regurgitation (FTR) occurs due to annular dilatation in association with left sided valve disease and is more commonly seen than primary pathology in patients with Rheumatic mitral valve disease. FTR occurs due to increased right ventricle after load that leads to either dilatation or geometric deformation of Tricuspid annulus. If left untreated, FTR may worsen and increase morbidity and mortality.

Official Title
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Comparison Between Outcomes Of Ring And Suture Annuloplasty For Functional Tricuspid Regurgitation In Rheumatic Mitral Valve Diseases

Conditions
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Functional Tricuspid Regurgitation

Intervention / Treatment
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* Procedure: Tricuspid Annuloplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The participants will be all patients between 15 to 75 years of age group diagnosed as a case of Rheumatic Mitral Valve disease with moderate to severe functional Tricuspid regurgitation. Exclusion Criteria: Patient with organic Tricuspid Valve (TV) lesion diagnosed in Echocardiography Patient with FTR requiring Mitral Valve repair Patient with FTR requiring concomitant aortic valve replacement Patient with FTR secondary to pathology other than Mitral valve disease

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group R (ring)<br>Patients in Group R will undergo tricuspid ring annuloplasty | Procedure: Tricuspid Annuloplasty<br>* Patients will undergo repair of tricuspid regurgitation<br>|
| Active Comparator: Group S (suture)<br>Patients in Group S will undergo De Vega's suture annuloplasty | Procedure: Tricuspid Annuloplasty<br>* Patients will undergo repair of tricuspid regurgitation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in severity of FTR | Definitions: Improvement in FTR: refers to Mild or No TR Tricuspid regurgitation is graded as mild, moderate, and severe based on regurgitant jet area i. <5cm2 = Mild ii. 6-10cm2 = Moderate iii. >10cm2 = Severe | within 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Mortality: Mortality within hospital stay or 3 months postoperative. | up to 3 months of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ring Annuloplasty, Suture Annuloplasty, Functional Tricuspid Regurgitation