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

Functional Tricuspid Regurgitation Clinical Trial

Official title:

Comparison Between Outcomes Of Ring And Suture Annuloplasty For Functional Tricuspid Regurgitation In Rheumatic Mitral Valve Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02721524
• Other study ID #: TRICUSPID STUDY-RCT
• Status: Recruiting
• Phase: N/A
• First received: March 16, 2016
• Last updated: March 22, 2016
• Start date: November 2015
• Est. completion date: September 2016

Study information

• Verified date: March 2016
• Source: Shahid Gangalal National Heart Centre
• Contact: Binita Tamrakar, RN
• Phone: +97714371322
• Email: ircsgnhc[@]gmail.com
• Is FDA regulated: No
• Health authority: Nepal: Health Research Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Functional Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

Procedure:
• Tricuspid Annuloplasty
Patients will undergo repair of tricuspid regurgitation

Locations

Country	Name	City	State
Nepal	Shahid Gangalal National Heart Centre	Kathmandu	Bagmati

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Gangalal National Heart Centre

Country where clinical trial is conducted

Nepal, 

References & Publications (8)

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. Review. — View 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. — View 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. — View 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 — View 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. — View 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. Review. — View Citation

Sarralde JA, Bernal JM, Llorca J, Pontón A, Diez-Solorzano L, Giménez-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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	within 3 months	No
Secondary	Mortality	Mortality: Mortality within hospital stay or 3 months postoperative.	up to 3 months of intervention	No