Prospective Registry of Patients With Isolated Severe Tricuspid Regurgitation

NCT ID: NCT01502462

Last Updated: 2021-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

131 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2020-12-30

Brief Summary

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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

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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)

Conditions

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Tricuspid Regurgitation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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)
Minimum Eligible Age

16 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jong-Min Song

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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Severe_Isol_TR

Identifier Type: -

Identifier Source: org_study_id

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