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

S

Shahid Gangalal National Heart Centre

Status

Unknown

Conditions

Functional Tricuspid Regurgitation

Treatments

Procedure: Tricuspid Annuloplasty

Study type

Interventional

Funder types

Other

Identifiers

NCT02721524
TRICUSPID STUDY-RCT

Details and patient eligibility

About

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.

Full 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.

Enrollment

86 estimated patients

Sex

All

Ages

14 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

86 participants in 2 patient groups

Group R (ring)
Active Comparator group
Description:
Patients in Group R will undergo tricuspid ring annuloplasty
Treatment:
Procedure: Tricuspid Annuloplasty
Group S (suture)
Active Comparator group
Description:
Patients in Group S will undergo De Vega's suture annuloplasty
Treatment:
Procedure: Tricuspid Annuloplasty

Trial contacts and locations

1

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Central trial contact

Binita Tamrakar, RN

Data sourced from clinicaltrials.gov

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