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)

• Conditions: Tricuspid Regurgitation; Congenital Heart Disease; Systemic Right Ventricle
• Interventions: Device: Edge to edge repair in systemic tricuspid valve regurgitation

• Registration Number: NCT05052177
• Lead Sponsor: University of Bordeaux

Brief Summary

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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Detailed Description

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.

Study Timeline

• Study Start: 2020-07-01
• Status Verified: 2021-09
• Study First Submitted: 2021-09-02
• Study First Submitted QC: 2021-09-10
• Last Update Submitted: 2021-09-10
• Study First Posted: 2021-09-22
• Last Update Posted: 2021-09-22
• Primary Completion: 2022-10-30
• Study Completion: 2022-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient with systemic right ventricles with severe tricuspid regurgitation and high surgical risk	Edge to edge repair in systemic tricuspid valve regurgitation	* 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

Primary Outcome Measures

Name	Time	Method
Clinical, VO2 max testing, biological, echocardiographic, cross-sectionnal Imaging data.	2 years	Clinical data : dyspnea (NYHA 1/2/3/4), heart palpitations (yes/no), heart failure in the 6 previous months (yes/no)
Biological data.	2 years	Biological data : hemoglobine (g/dL), hematocrit (%), creatinine (µmol/L), BNP/nt-proBNP (ng/mL) at baseline, 6, 12, 24 months
VO2 max testing data.	2 years	VO2 max testing: VO2 max (ml/min/kg), strenght in watts
Echographic data.	2 years	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
Cross-sectionnal Imaging data.	2 years	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.

Trial Locations

Locations (1)

Bordeaux University Hospital; 🇫🇷 Bordeaux, France