|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
11 April 2016 |
|
Main ID: |
NCT02721524 |
|
Date of registration:
|
16/03/2016 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Ring Versus Suture Annuloplasty For Functional Tricuspid Regurgitation In Rheumatic Mitral Valve Diseases
|
|
Scientific title:
|
Comparison Between Outcomes Of Ring And Suture Annuloplasty For Functional Tricuspid Regurgitation In Rheumatic Mitral Valve Diseases |
|
Date of first enrolment:
|
November 2015 |
|
Target sample size:
|
86 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT02721524 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Nepal
| | | | | | | |
|
Contacts
|
|
Name:
|
Binita Tamrakar, RN |
|
Address:
|
|
|
Telephone:
|
+97714371322 |
|
Email:
|
ircsgnhc@gmail.com |
|
Affiliation:
|
|
|
|
Name:
|
Binita Tamrakar, RN |
|
Address:
|
|
|
Telephone:
|
+97714371322 |
|
Email:
|
ircsgnhc@gmail.com |
|
Affiliation:
|
|
|
|
Name:
|
Marisha Aryal, MBBS |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Shahid Gangalal National Heart Centre |
|
|
Key inclusion & exclusion 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
Age minimum:
14 Years
Age maximum:
75 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Functional Tricuspid Regurgitation
|
|
Intervention(s)
|
|
Procedure: Tricuspid Annuloplasty
|
|
Primary Outcome(s)
|
|
Improvement in severity of FTR
[Time Frame: within 3 months]
|
|
Secondary Outcome(s)
|
|
Mortality
[Time Frame: up to 3 months of intervention]
|
|
Secondary ID(s)
|
|
TRICUSPID STUDY-RCT
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|