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NCT01502462 Clinical Trial

Prospective Registry of Patients With Isolated Severe Tricuspid Regurgitation

Tricuspid Regurgitation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01502462
Other study ID # Severe_Isol_TR
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2012
Est. completion date December 30, 2020

Study information
Verified date February 2021
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Prospective registry for patients with severe isolated tricuspid regurgitation (TR) without significant left-sided valvular or myocardial diseases. Aim: To evaluate clinical course and prognostic factors of patients with severe isolated TR.

Description:

Inclusion criteria Severe isolated TR for more than 6 months Exclusion criteria 1. Severe mitral and aortic valvular heart disease 2. Age equals to or more than 75 years 3. Malignancy or serious comorbidity with life expectancy < 5years 4. Acute or subacute infective endocarditis requiring antibiotics therapy 5. Untreated hyperthyroidism 6. Constrictive pericarditis 7. Unclosed significant atrial septal defect 8. Previous tricuspid valve surgery 9. Significant coronary artery disease 10. Cardiomyopathy 11. Pregnancy 12. Severe resting pulmonary hypertension(TR Vmax >4.0 m/s)

Recruitment information / eligibility
Status Completed
Enrollment 131
Est. completion date December 30, 2020
Est. primary completion date December 30, 2020
Accepts healthy volunteers No
Gender All
Age group 16 Years to 75 Years
Eligibility Inclusion criteria - Severe isolated TR for more than 6 months Exclusion criteria 1. Severe mitral and aortic valvular heart disease 2. Age equals to or more than 75 years 3. Malignancy or serious comorbidity with life expectancy < 5years 4. Acute or subacute infective endocarditis requiring antibiotics therapy 5. Untreated hyperthyroidism 6. Constrictive pericarditis 7. Unclosed significant atrial septal defect 8. Previous tricuspid valve surgery 9. Significant coronary artery disease 10. Cardiomyopathy 11. Pregnancy 12. Severe resting pulmonary hypertension(TR Vmax >4.0 m/s)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary all cause death 5 years
Secondary Hospitalization of cardiovascular causes 5 years
Secondary tricuspid valve surgery 5 years
Secondary stroke 5 years
See also
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