Clinical trial NCT05052177: 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)
Official title: 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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systemic Right Ventricle
Tricuspid Regurgitation
Congenital Heart Disease
Lead sponsor: University of Bordeaux
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with systemic right ventricle who underwent a percutaneous edge to edge systemic valve repair for the treatment of severe tricuspid valve regurgitation.

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

.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinical, VO2 max testing, biological, echocardiographic, cross-sectionnal Imaging data.
timeFrame: 2 years
measure: VO2 max testing data.
timeFrame: 2 years
measure: Biological data.
timeFrame: 2 years
measure: Echographic data.
timeFrame: 2 years
measure: Cross-sectionnal Imaging data.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Bordeaux University Hospital
Study officials:
affiliation: University Hospital, Bordeaux
name: Alexandre SILINI
role: PRINCIPAL_INVESTIGATOR
References: