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

Not Applicable

• Conditions: Functional Tricuspid Regurgitation
• Interventions: Procedure: Tricuspid Annuloplasty

• Registration Number: NCT02721524
• Lead Sponsor: Shahid Gangalal National Heart Centre

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-11
• Status Verified: 2016-03
• Study First Submitted: 2016-03-16
• Study First Submitted QC: 2016-03-22
• Last Update Submitted: 2016-03-22
• Study First Posted: 2016-03-29
• Last Update Posted: 2016-03-29
• Primary Completion: 2016-09
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group R (ring)	Tricuspid Annuloplasty	Patients in Group R will undergo tricuspid ring annuloplasty
Group S (suture)	Tricuspid Annuloplasty	Patients in Group S will undergo De Vega's suture annuloplasty

Primary Outcome Measures

Name	Time	Method
Improvement in severity of FTR	within 3 months	Definitions: 1. Improvement in FTR: refers to Mild or No TR; 2. Tricuspid regurgitation is graded as mild, moderate, and severe based on regurgitant jet area i. \<5cm2 = Mild ii. 6-10cm2 = Moderate iii. \>10cm2 = Severe

Secondary Outcome Measures

Name	Time	Method
Mortality	up to 3 months of intervention	Mortality: Mortality within hospital stay or 3 months postoperative.

Trial Locations

Locations (1)

Shahid Gangalal National Heart Centre; 🇳🇵 Kathmandu, Bagmati, Nepal