- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01537458
Long-term Outcome After Isolated Tricuspid Valve Repair
Tricuspid valve insufficiency (TI) is often noted on echocardiography. Although severe TI is known to cause significant morbidity and mortality, no good guidelines are available to guide intervention. Literature is mostly confined to tricuspid valve repair concomitant with mitral valve repair. Treatment options for isolated repair have not been investigated thoroughly.
The investigators want to evaluate retrospectively the outcome of isolated tricuspid valve repair, performed in our center. By doing this, the investigators want to evaluate predictors of outcome after repair.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Vlaams-Brabant
-
Leuven, Vlaams-Brabant, Belgium, 3000
- University Hospitals Leuven
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- tricuspid valve insufficiency
Exclusion Criteria:
- younger than 18 years
- associated valvular surgery
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Isolated TI repair
Patients that underwent isolated tricuspid valve repair
|
follow-up of patients that underwent TV repair in the past.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
mortality
Time Frame: 10 year
|
10 year
|
Redo surgery
Time Frame: 10 year
|
10 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
functional capacity assessed by CPET
Time Frame: 10 year
|
10 year
|
|
Atrial fibrillation
Time Frame: 10 year
|
10 year
|
|
Hospitalisation
Time Frame: 10 year
|
hospitalisation for cardiovascular reasons
|
10 year
|
Functional capacity assessed by NYHA functional class
Time Frame: 10 years
|
10 years
|
Collaborators and Investigators
Collaborators
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
- Is_TVR_1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tricuspid Valve Insufficiency
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Medical College of WisconsinChildren's Hospital and Health System Foundation, WisconsinCompletedMitral Valve Regurgitation | Tricuspid Valve Regurgitation, Non-rheumaticUnited States
-
Edwards LifesciencesActive, not recruitingTricuspid Regurgitation | Tricuspid InsufficiencyGermany, Spain, Switzerland
-
VDyne, Inc.RecruitingTricuspid Regurgitation | Tricuspid Valve Disease | Tricuspid Valvular DisordersAustralia, Czechia, Austria
-
Azienda Ospedaliero, Universitaria PisanaNot yet recruitingSevere Tricuspid Valve Regurgitation
-
CroiValve LimitedRecruitingHeart Valve Diseases | Tricuspid Valve Insufficiency | Tricuspid Regurgitation | Tricuspid Valve DiseaseUnited States
-
Baylor Research InstituteTerminatedTricuspid Regurgitation | Tricuspid Valve DiseaseUnited States
-
VDyne, Inc.Not yet recruitingTricuspid Regurgitation | Tricuspid Valve Disease | Tricuspid Valvular DisordersUnited States
-
P+F Products + Features GmbHMeditrial USA Inc.Not yet recruitingTricuspid Regurgitation | Tricuspid Valve DiseaseUnited States
-
Michele De BonisCompleted
-
P+F Products + Features GmbHRecruitingHeart Diseases | Heart Failure | Heart Valve Diseases | Tricuspid Valve Insufficiency | Tricuspid Regurgitation | Tricuspid InsufficiencySpain, Germany, Austria, Belgium, Lithuania
Clinical Trials on follow-up of isolated tricuspid valve repair
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Saint Petersburg State University, RussiaSuspended
-
Minia UniversityCompletedFunctional Tricuspid Regurgitation
-
University of Maryland, BaltimoreEdwards LifesciencesCompletedCardiac Surgery | Tricuspid Valve RegurgitationUnited States
-
Abbott Medical DevicesActive, not recruitingTricuspid Valve InsufficiencySpain, United States, Switzerland, Germany, France, Italy
-
Edwards LifesciencesActive, not recruitingTricuspid Regurgitation | Tricuspid InsufficiencyGermany, Spain, Switzerland
-
Medtronic CardiovascularCompletedTricuspid Valve Regurgitation | Tricuspid Valve InsufficiencyUnited States
-
Ettore Sansavini Health Science FoundationUnknownTricuspid Valve InsufficiencyItaly
-
Xijing HospitalNot yet recruitingTricuspid Regurgitation
-
Helios Klinikum PforzheimRecruitingRight Heart Failure | Tricuspid Regurgitation | Cardiac Remodeling, Ventricular | Cardiac Remodeling, AtrialGermany
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Hangzhou Valgen Medtech Co., LtdRecruitingTricuspid RegurgitationChina