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)

NCT05052177 | Unknown FDA Device

• 1 other identifier: University of Bordeaux
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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 .

Conditions

Systemic Right Ventricle; Tricuspid Regurgitation; Congenital Heart Disease

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

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

* 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

Interventions

Edge to edge repair in systemic tricuspid valve regurgitation DEVICE

Edge to edge repair of severe tricuspid regurgitation on a right systemic ventricle with a Mitraclip device.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \> 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

You may not qualify if:

• pregnant
• breastfeeding women

Sponsors & Collaborators

• University of Bordeaux: lead

Study Sites (1)

Bordeaux University Hospital

Bordeaux, 33000, France

RECRUITING

Related 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.

MeSH Terms

Conditions

Tricuspid Valve Insufficiency; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Alexandre SILINI

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandre SILINI

CONTACT

0678746867; alexandre.silini@gmail.com

Xavier IRIART, MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Intern

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 22, 2021
• Study Start: July 1, 2020
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: September 22, 2021

Record last verified: 2021-09

Locations

FR (1)