Prospective Registry of Patients With Isolated Severe Tricuspid Regurgitation

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01502462

Enrollment

131

Registered

2011-12-30

Start date

2012-02-29

Completion date

2020-12-30

Last updated

2021-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tricuspid Regurgitation

Keywords

Clinical course and prognostic factors in patients with severe isolated TR

Brief 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.

Detailed 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)

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to 75 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
all cause death	5 years

Secondary

Measure	Time frame
Hospitalization of cardiovascular causes	5 years
tricuspid valve surgery	5 years
stroke	5 years

Countries

South Korea

Outcome results