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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group R (ring) | Active Comparator | Patients in Group R will undergo tricuspid ring annuloplasty |
|
| Group S (suture) | Active Comparator | Patients in Group S will undergo De Vega's suture annuloplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tricuspid Annuloplasty | Procedure | Patients will undergo repair of tricuspid regurgitation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in severity of FTR | Definitions:
| within 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Mortality: Mortality within hospital stay or 3 months postoperative. | up to 3 months of intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Binita Tamrakar, RN | Contact | +97714371322 | 576 | ircsgnhc@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Marisha Aryal, MBBS | Shahid Gangalal National Heart Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shahid Gangalal National Heart Centre | Recruiting | Kathmandu | Bagmati | 44606 | Nepal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16820641 | Background | 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. | |
| 22627660 | Background | 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. |
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| 20667339 | Background | 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. |
| 3881631 | Background | 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. |
| 23303656 | Background | 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. |
| 19470900 | Result | 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. |
| 15001895 | Result | 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. |
| 20394950 | Result | 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. |