- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03604484
Prophylactic Tricuspid Annuloplasty During Mitral Valve Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The optimal management of functional tricuspid regurgitation (FTR) in the setting of mitral valve operations remains controversial. The current practice is both center- and surgeon-specific with guidelines based on non-randomized data. A prospective randomized trial was performed to evaluate the worth of less-than-severe FTR repair during mitral valve procedures.
A single center randomized study was designed to allocate patients with less-than-severe FTR undergoing mitral valve surgery to be prophylactically treated + tricuspid valve annuloplasty (TVP- or TVP+). These patients were analysed using longitudinal cardiopulmonary exercise capacity, echocardiographic follow-up, and cardiac magnetic resonance (CMR). The primary outcome was more than mild tricuspid regurgitation (TR) recurrence with vena contracta >3mm. Secondary outcomes were maximal oxygen uptake (VO2 max) and right ventricular (RV) dimension and function.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients undergoing mitral valve surgery with less than sever tricuspid insufficiency
Exclusion Criteria:
- presence of pacemaker lead through the tricuspid valve
- acute endocarditis
- minimally invasive approach
- Functional mitral valve insufficiency
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Tricuspid annuloplasty
Patient treated with tricuspid annuloplasty at the moment of the mitral valve surgery
|
Tricuspid annuloplasty
|
No Intervention: No Tricuspid annuloplasty
Control patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of more than mild tricuspid insufficiency
Time Frame: 5 year
|
5 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VO2 max
Time Frame: 1 year
|
Physical function capacity measured by VO2 max
|
1 year
|
Right ventricular function
Time Frame: 5 year
|
Right ventricle function at the follow up
|
5 year
|
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 (Actual)
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
- UCLSaint Luc
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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
-
VDyne, Inc.RecruitingTricuspid Regurgitation | Tricuspid Valve Disease | Tricuspid Valvular DisordersAustralia, Czechia, Austria
-
Edwards LifesciencesActive, not recruitingTricuspid Regurgitation | Tricuspid InsufficiencyGermany, Spain, Switzerland
-
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
-
P+F Products + Features GmbHRecruitingHeart Diseases | Heart Failure | Heart Valve Diseases | Tricuspid Valve Insufficiency | Tricuspid Regurgitation | Tricuspid InsufficiencySpain, Germany, Austria, Belgium, Lithuania
-
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
Clinical Trials on Tricuspid annuloplasty
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Shahid Gangalal National Heart CentreUnknownFunctional Tricuspid RegurgitationNepal
-
Nanjing Medical UniversityAffiliated Hospital of Nantong UniversityRecruiting
-
Hasselt UniversityUnknownTricuspid Valve InsufficiencyBelgium
-
University of Maryland, BaltimoreEdwards LifesciencesCompletedCardiac Surgery | Tricuspid Valve RegurgitationUnited States
-
Ettore Sansavini Health Science FoundationUnknownTricuspid (Valve) Insufficiency (Rheumatic)Italy
-
Michele De BonisCompletedFunctional Tricuspid RegurgitationItaly
-
Medtronic Bakken Research CenterCompletedTricuspid Valve InsufficiencyFrance, Israel, Germany
-
Mitralign, Inc.CardioVascular Research Foundation, Korea; Regulatory and Clinical Research... and other collaboratorsUnknownHeart Valve Disease | Tricuspid Valve Insufficiency | Chronic Symptomatic Functional Tricuspid RegurgitationItaly, Netherlands, Germany, Portugal
-
Mitralign, Inc.UnknownHeart Valve Disease | Tricuspid Valve Insufficiency | Chronic Symptomatic Functional Tricuspid RegurgitationUnited States
-
Guangzhou General Hospital of Guangzhou Military...RecruitingAtrial Fibrillation | Valvular Heart DiseaseChina