Percutaneous Edge To Edge Repair for the Treatment of Severe Tricuspid Valve Regurgitation in High-surgical Risk Patients With Systemic Right Ventricle : a Multicentric French Cohort (PETER-TRESRIV)

Study Overview
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Brief Summary
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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 .

Detailed Description
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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.

Official Title
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Percutaneous Edge To Edge Repair for the Treatment of Severe Tricuspid Valve Regurgitation in High-surgical Risk Patients With Systemic Right Ventricle : a Multicentric French Cohort.

Conditions
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Systemic Right Ventricle, Tricuspid Regurgitation, Congenital Heart Disease

Intervention / Treatment
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* Device: Edge to edge repair in systemic tricuspid valve regurgitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 18-years-old Right systemic ventricle Severe tricuspid regurgitation Symptomatic patient (NYHA 2 - 4) despite optimal medical therapy High-risk surgical patient deemed not eligible for surgery by a multi-disciplinary and thus having underwent a percutaneous treatment of tricuspid regurgitation Exclusion Criteria: pregnant breastfeeding women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient with systemic right ventricles with severe tricuspid regurgitation and high surgical risk<br>inclusion criteria: > 18-years-old Right systemic ventricle Severe tricuspid regurgitation Symptomatic patient (NYHA 2 - 4) despite optimal medical therapy High-risk surgical patient deemed not eligible for surgery by a multi-disciplinary and thus having underwent a percutaneous treatment of tricuspid regurgitation exclusion criteria - pregnant ou breastfeeding women | Device: Edge to edge repair in systemic tricuspid valve regurgitation<br>* Edge to edge repair of severe tricuspid regurgitation on a right systemic ventricle with a Mitraclip device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |