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Single center randomized study to test whether a prophylactic tricuspid annuloplasty at the time of mitral valve procedure can improve clinical and echocardiographical outcomes.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tricuspid annuloplasty | Active Comparator | Patient treated with tricuspid annuloplasty at the moment of the mitral valve surgery |
|
| No Tricuspid annuloplasty | No Intervention | Control patients |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tricuspid annuloplasty | Procedure | Tricuspid annuloplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of more than mild tricuspid insufficiency | 5 year |
| Measure | Description | Time Frame |
|---|---|---|
| VO2 max | Physical function capacity measured by VO2 max | 1 year |
| Right ventricular function | Right ventricle function at the follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 2, 2020 | |
| Reset | Nov 24, 2020 | |
| Release | May 3, 2021 | |
| Reset | May 25, 2021 | |
| Release | May 17, 2022 | |
| Reset | May 19, 2022 | |
| Release | May 20, 2022 | |
| Reset | May 20, 2022 | |
| Release | Jul 23, 2024 | |
| Reset | Jul 25, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 2, 2020 | Nov 24, 2020 | |||
| May 3, 2021 |
| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 5 year |
| May 25, 2021 |
| May 17, 2022 | May 19, 2022 |
| May 20, 2022 | May 20, 2022 |
| Jul 23, 2024 | Jul 25, 2024 |