Clinical trial NCT02721524: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Functional Tricuspid Regurgitation
Keywords: Ring Annuloplasty
Suture Annuloplasty
Functional Tricuspid Regurgitation
Lead sponsor: Shahid Gangalal National Heart Centre
Sponsor class: OTHER
First posted: 2016-03-29
Enrollment: 86
Sex: ALL
Minimum age (years): 14
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Improvement in severity of FTR
timeFrame: within 3 months
Secondary outcomes:
measure: Mortality
timeFrame: up to 3 months of intervention
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Shahid Gangalal National Heart Centre
state: Bagmati
Study officials:
affiliation: Shahid Gangalal National Heart Centre
name: Marisha Aryal, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.