- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01502462
Prospective Registry of Patients With Isolated Severe Tricuspid Regurgitation
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.
Study Overview
Status
Conditions
Detailed Description
Inclusion criteria Severe isolated TR for more than 6 months
Exclusion criteria
- Severe mitral and aortic valvular heart disease
- Age equals to or more than 75 years
- Malignancy or serious comorbidity with life expectancy < 5years
- Acute or subacute infective endocarditis requiring antibiotics therapy
- Untreated hyperthyroidism
- Constrictive pericarditis
- Unclosed significant atrial septal defect
- Previous tricuspid valve surgery
- Significant coronary artery disease
- Cardiomyopathy
- Pregnancy
- Severe resting pulmonary hypertension(TR Vmax >4.0 m/s)
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Seoul, Korea, Republic of, 138-736
- Asan Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
- Severe mitral and aortic valvular heart disease
- Age equals to or more than 75 years
- Malignancy or serious comorbidity with life expectancy < 5years
- Acute or subacute infective endocarditis requiring antibiotics therapy
- Untreated hyperthyroidism
- Constrictive pericarditis
- Unclosed significant atrial septal defect
- Previous tricuspid valve surgery
- Significant coronary artery disease
- Cardiomyopathy
- Pregnancy
- Severe resting pulmonary hypertension(TR Vmax >4.0 m/s)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
all cause death
Time Frame: 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
stroke
Time Frame: 5 years
|
5 years
|
Hospitalization of cardiovascular causes
Time Frame: 5 years
|
5 years
|
tricuspid valve surgery
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Severe_Isol_TR
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Clinical Trials on Tricuspid Regurgitation
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Icahn School of Medicine at Mount SinaiNational Heart, Lung, and Blood Institute (NHLBI); Canadian Institutes of Health... and other collaboratorsActive, not recruitingTricuspid Regurgitation | Mild Tricuspid Regurgitation | Moderate Tricuspid RegurgitationUnited States, Canada, Germany
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IRCCS Policlinico S. DonatoRecruitingTricuspid Regurgitation CongenitalItaly
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University of ZurichRecruitingSevere Tricuspid RegurgitationSwitzerland
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P+F Products + Features GmbHCompletedSevere Tricuspid RegurgitationLithuania
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Innoventric LTDNot yet recruitingTricuspid Regurgitation | Tricuspid Regurgitation Functional
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Charite University, Berlin, GermanyRecruitingFunctional Tricuspid RegurgitationGermany, Israel
-
Michele De BonisCompleted
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P+F Products + Features GmbHCompletedSevere Tricuspid RegurgitationSpain, Austria
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TriFlo Cardiovascular, Inc.Not yet recruitingSymptomatic Severe Tricuspid RegurgitationItaly