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

March 22, 2016 updated by: Marisha Aryal, Shahid Gangalal National Heart Centre

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Nepal
    • Bagmati
      • Kathmandu, Bagmati, Nepal, 44606
        • Recruiting
        • Shahid Gangalal National Heart Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in severity of FTR
Time Frame: 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
within 3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Gangalal National Heart Centre

Investigators

  • Principal Investigator: Marisha Aryal, MBBS, Shahid Gangalal National Heart Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

March 16, 2016

First Submitted That Met QC Criteria

March 22, 2016

First Posted (Estimate)

March 29, 2016

Study Record Updates

Last Update Posted (Estimate)

March 29, 2016

Last Update Submitted That Met QC Criteria

March 22, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRICUSPID STUDY-RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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