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)

University of Bordeaux

Status: Unknown

Conditions: Systemic Right Ventricle; Congenital Heart Disease; Tricuspid Regurgitation

Treatments: Device: Edge to edge repair in systemic tricuspid valve regurgitation

Study type: Observational

Funder types: Other

Identifiers

NCT05052177

University of Bordeaux

Details and patient eligibility

About

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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Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

10 participants in 1 patient group

Patient with systemic right ventricles with severe tricuspid regurgitation and high surgical risk

Description:

* 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

Treatment:

Device: Edge to edge repair in systemic tricuspid valve regurgitation