NCT02721524

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 29, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

March 29, 2016

Status Verified

March 1, 2016

Enrollment Period

10 months

First QC Date

March 16, 2016

Last Update Submit

March 22, 2016

Conditions

Functional Tricuspid Regurgitation

Keywords

Ring AnnuloplastySuture AnnuloplastyFunctional Tricuspid Regurgitation

Outcome Measures

Primary Outcomes (1)

  • Improvement in severity of FTR

    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 Outcomes (1)

  • Mortality

    up to 3 months of intervention

Study Arms (2)

Group R (ring)

ACTIVE COMPARATOR

Patients in Group R will undergo tricuspid ring annuloplasty

Procedure: Tricuspid Annuloplasty

Group S (suture)

ACTIVE COMPARATOR

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

Procedure: Tricuspid Annuloplasty

Interventions

Tricuspid AnnuloplastyPROCEDURE

Patients will undergo repair of tricuspid regurgitation

Group R (ring)Group S (suture)

Eligibility Criteria

Age14 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shahid Gangalal National Heart Centre

Kathmandu, Bagmati, 44606, Nepal

RECRUITING

Related Publications (8)

  • 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.

    PMID: 16820641BACKGROUND

  • 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.

    PMID: 22627660BACKGROUND

  • 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.

    PMID: 20667339BACKGROUND

  • 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.

    PMID: 3881631BACKGROUND

  • 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.

    PMID: 23303656BACKGROUND

  • 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.

    PMID: 19470900RESULT

  • 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.

    PMID: 15001895RESULT

  • 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.

    PMID: 20394950RESULT

Study Officials

  • Marisha Aryal, MBBS

    Shahid Gangalal National Heart Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Binita Tamrakar, RN

CONTACT

+97714371322ircsgnhc@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident, Cardiac Surgery Dept.

Study Record Dates

First Submitted

March 16, 2016

First Posted

March 29, 2016

Study Start

November 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

March 29, 2016

Record last verified: 2016-03

Locations

NE(1)