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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02721524

Enrollment

Registered

2016-03-29

Start date

2015-11-30

Completion date

2016-09-30

Last updated

2016-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Tricuspid Regurgitation

Keywords

Ring Annuloplasty, Suture Annuloplasty, Functional Tricuspid Regurgitation

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.

Interventions

PROCEDURETricuspid Annuloplasty

Patients will undergo repair of tricuspid regurgitation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

14 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Mortality	up to 3 months of intervention	Mortality: Mortality within hospital stay or 3 months postoperative.

Countries

Nepal

Contacts

Primary ContactBinita Tamrakar, RN

ircsgnhc@gmail.com+97714371322

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026