Prospective Registry of Patients With Isolated Severe Tricuspid Regurgitation

Completed

• Conditions: Tricuspid Regurgitation

• Registration Number: NCT01502462
• Lead Sponsor: Asan Medical Center

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)

Study Timeline

• Study First Submitted: 2011-12-29
• Study First Submitted QC: 2011-12-29
• Study First Posted: 2011-12-30
• Study Start: 2012-02
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
all cause death	5 years

Secondary Outcome Measures

Name	Time	Method
stroke	5 years
Hospitalization of cardiovascular causes	5 years
tricuspid valve surgery	5 years

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of