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Our study is about to follow adult congenital patients, known with systemic right ventricle (mostly correct transposition of the great arteries ou congenitally corrected transposition fo the great arteries) and systemic valve severe regurgitation which was treated with a Mitraclip device on this tricuspid valve.
It's an observationnal study with a 2 years follow up with clinical (symptoms, complications, VO2 exercice test) echographic and MRI outcomes
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Patients with systemic right ventricle (mostly congenitally-corrected transposition of the great arteries or transposition of the great arteries corrected by atrial switch) commonly develop significant systemic tricuspid valve regurgitation which is a therapeutic dilemma for the care team. Surgery (valvuloplasty or replacement) is the common and historical treatment but the rate of mortality is high and results about long-term benefit are contradicting. Percutaneous edge to edge repair could be a alternative to surgery.
10 high-risk surgical patients with severe systemic tricuspid regurgitation undergoing a percutaneous repair were included between January 2019 and November 2022. Our study is a retrospective analysis of short and mid-term clinical, biological, echocardiographic and MRI/TDM outcomes with an expected minimum follow-up of 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with systemic right ventricles with severe tricuspid regurgitation and high surgical risk |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edge to edge repair in systemic tricuspid valve regurgitation | Device | Edge to edge repair of severe tricuspid regurgitation on a right systemic ventricle with a Mitraclip device. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical, VO2 max testing, biological, echocardiographic, cross-sectionnal Imaging data. | Clinical data : dyspnea (NYHA 1/2/3/4), heart palpitations (yes/no), heart failure in the 6 previous months (yes/no) | 2 years |
| VO2 max testing data. | VO2 max testing: VO2 max (ml/min/kg), strenght in watts | 2 years |
| Biological data. | Biological data : hemoglobine (g/dL), hematocrit (%), creatinine (µmol/L), BNP/nt-proBNP (ng/mL) at baseline, 6, 12, 24 months | 2 years |
| Echographic data. | Echocardiographic data : tricuspid insuffisency severity (régurgitant orifice area in mm²), régurgitant volume (mL)), tricuspid annular diameter (cm), and right ventricle systemic function (S'VD in cm/s, TAPSE in mm, shortening right ventricle fraction in %), and area (end-diastolic and end-systolic area) at baseline, 6, 12, 24 months | 2 years |
| Cross-sectionnal Imaging data. | Cross-sectionnal imaging data : quantitative parameters of tricuspid regurgitation (regurgitant volume in mL, percentage of regurgitation in %) and right ventricle systemic function (ejection fraction in %) and volume (end-diastolic and end-systolic volume in mL) at baseline and 6 months. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with systemic right ventricle who underwent a percutaneous edge to edge systemic valve repair for the treatment of severe tricuspid valve regurgitation.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandre SILINI | Contact | 0678746867 | alexandre.silini@gmail.com | |
| Xavier IRIART, MD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Alexandre SILINI | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bordeaux University Hospital | Recruiting | Bordeaux | 33000 | France |
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| Label | URL |
|---|---|
| Filippov AA, del Nido PJ, Vasilyev NV. Management of Systemic Right Ventricular Failure in Patients With Congenitally Corrected Transposition of the Great Arteries. Circulation. 25 oct 2016;134(17):1293-302. | View source |
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| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D018376 | Cardiovascular Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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