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

Primary Purpose

Functional Tricuspid Regurgitation

Status
Unknown status
Phase
Not Applicable
Locations
Nepal
Study Type
Interventional
Intervention
Tricuspid Annuloplasty
Sponsored by
Shahid Gangalal National Heart Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Tricuspid Regurgitation focused on measuring Ring Annuloplasty, Suture Annuloplasty, Functional Tricuspid Regurgitation

Eligibility Criteria

14 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Shahid Gangalal National Heart CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group R (ring)

Group S (suture)

Arm Description

Patients in Group R will undergo tricuspid ring annuloplasty

Patients in Group S will undergo De Vega's suture annuloplasty

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mortality
Mortality: Mortality within hospital stay or 3 months postoperative.

Full Information

First Posted
March 16, 2016
Last Updated
March 22, 2016
Sponsor
Shahid Gangalal National Heart Centre
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1. Study Identification

Unique Protocol Identification Number
NCT02721524
Brief Title
Ring Versus Suture Annuloplasty For Functional Tricuspid Regurgitation In Rheumatic Mitral Valve Diseases
Official Title
Comparison Between Outcomes Of Ring And Suture Annuloplasty For Functional Tricuspid Regurgitation In Rheumatic Mitral Valve Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Gangalal National Heart Centre

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Tricuspid Regurgitation
Keywords
Ring Annuloplasty, Suture Annuloplasty, Functional Tricuspid Regurgitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group R (ring)
Arm Type
Active Comparator
Arm Description
Patients in Group R will undergo tricuspid ring annuloplasty
Arm Title
Group S (suture)
Arm Type
Active Comparator
Arm Description
Patients in Group S will undergo De Vega's suture annuloplasty
Intervention Type
Procedure
Intervention Name(s)
Tricuspid Annuloplasty
Intervention Description
Patients will undergo repair of tricuspid regurgitation
Primary Outcome Measure Information:
Title
Improvement in severity of FTR
Description
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
Time Frame
within 3 months
Secondary Outcome Measure Information:
Title
Mortality
Description
Mortality: Mortality within hospital stay or 3 months postoperative.
Time Frame
up to 3 months of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Binita Tamrakar, RN
Phone
+97714371322
Ext
576
Email
ircsgnhc@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marisha Aryal, MBBS
Organizational Affiliation
Shahid Gangalal National Heart Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shahid Gangalal National Heart Centre
City
Kathmandu
State/Province
Bagmati
ZIP/Postal Code
44606
Country
Nepal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Binita Tamrakar, RN
Phone
+97714371322
Ext
576
Email
ircsgnhc@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
16820641
Citation
Tang GH, David TE, Singh SK, Maganti MD, Armstrong S, Borger MA. Tricuspid valve repair with an annuloplasty ring results in improved long-term outcomes. Circulation. 2006 Jul 4;114(1 Suppl):I577-81. doi: 10.1161/CIRCULATIONAHA.105.001263.
Results Reference
background
PubMed Identifier
22627660
Citation
Guenther T, Mazzitelli D, Noebauer C, Hettich I, Tassani-Prell P, Voss B, Lange R. Tricuspid valve repair: is ring annuloplasty superior? Eur J Cardiothorac Surg. 2013 Jan;43(1):58-65; discussion 65. doi: 10.1093/ejcts/ezs266. Epub 2012 May 24.
Results Reference
background
PubMed Identifier
20667339
Citation
Sarralde JA, Bernal JM, Llorca J, Ponton A, Diez-Solorzano L, Gimenez-Rico JR, Revuelta JM. Repair of rheumatic tricuspid valve disease: predictors of very long-term mortality and reoperation. Ann Thorac Surg. 2010 Aug;90(2):503-8. doi: 10.1016/j.athoracsur.2010.03.105.
Results Reference
background
PubMed Identifier
3881631
Citation
Rivera R, Duran E, Ajuria M. Carpentier's flexible ring versus De Vega's annuloplasty. A prospective randomized study. J Thorac Cardiovasc Surg. 1985 Feb;89(2):196-203.
Results Reference
background
PubMed Identifier
23303656
Citation
Badano LP, Muraru D, Enriquez-Sarano M. Assessment of functional tricuspid regurgitation. Eur Heart J. 2013 Jul;34(25):1875-85. doi: 10.1093/eurheartj/ehs474. Epub 2013 Jan 9.
Results Reference
background
PubMed Identifier
19470900
Citation
Rogers JH, Bolling SF. The tricuspid valve: current perspective and evolving management of tricuspid regurgitation. Circulation. 2009 May 26;119(20):2718-25. doi: 10.1161/CIRCULATIONAHA.108.842773.
Results Reference
result
PubMed Identifier
15001895
Citation
McCarthy PM, Bhudia SK, Rajeswaran J, Hoercher KJ, Lytle BW, Cosgrove DM, Blackstone EH. Tricuspid valve repair: durability and risk factors for failure. J Thorac Cardiovasc Surg. 2004 Mar;127(3):674-85. doi: 10.1016/j.jtcvs.2003.11.019.
Results Reference
result
PubMed Identifier
20394950
Citation
Navia JL, Nowicki ER, Blackstone EH, Brozzi NA, Nento DE, Atik FA, Rajeswaran J, Gillinov AM, Svensson LG, Lytle BW. Surgical management of secondary tricuspid valve regurgitation: annulus, commissure, or leaflet procedure? J Thorac Cardiovasc Surg. 2010 Jun;139(6):1473-1482.e5. doi: 10.1016/j.jtcvs.2010.02.046. Epub 2010 Apr 14.
Results Reference
result

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

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