Ring Versus Suture Annuloplasty For Functional Tricuspid Regurgitation In Rheumatic Mitral Valve Diseases
NCT ID: NCT02721524
Last Updated: 2016-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
86 participants
INTERVENTIONAL
2015-11-30
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group R (ring)
Patients in Group R will undergo tricuspid ring annuloplasty
Tricuspid Annuloplasty
Patients will undergo repair of tricuspid regurgitation
Group S (suture)
Patients in Group S will undergo De Vega's suture annuloplasty
Tricuspid Annuloplasty
Patients will undergo repair of tricuspid regurgitation
Interventions
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Tricuspid Annuloplasty
Patients will undergo repair of tricuspid regurgitation
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
14 Years
75 Years
ALL
No
Sponsors
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Shahid Gangalal National Heart Centre
OTHER
Responsible Party
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Marisha Aryal
Resident, Cardiac Surgery Dept.
Principal Investigators
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Marisha Aryal, MBBS
Role: PRINCIPAL_INVESTIGATOR
Shahid Gangalal National Heart Centre
Locations
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Shahid Gangalal National Heart Centre
Kathmandu, Bagmati, Nepal
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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TRICUSPID STUDY-RCT
Identifier Type: -
Identifier Source: org_study_id
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