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)

Congenital Heart Disease Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05052177
• Other study ID #: University of Bordeaux
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: October 30, 2022

Study information

• Verified date: September 2021
• Source: University of Bordeaux
• Contact: Alexandre SILINI
• Phone: 0678746867
• Email: alexandre.silini[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: October 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Systemic Right Ventricle
• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

Device:
• Edge to edge repair in systemic tricuspid valve regurgitation
Edge to edge repair of severe tricuspid regurgitation on a right systemic ventricle with a Mitraclip device.

Locations

Country	Name	City	State
France	Bordeaux University Hospital	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University of Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	VO2 max testing data.	VO2 max testing: VO2 max (ml/min/kg), strenght in watts	2 years
Primary	Biological data.	Biological data : hemoglobine (g/dL), hematocrit (%), creatinine (µmol/L), BNP/nt-proBNP (ng/mL) at baseline, 6, 12, 24 months	2 years
Primary	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
Primary	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

External Links

•   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.