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) (PETER-TRESRIV)

September 10, 2021 updated by: Alexandre Silini, University of Bordeaux

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.

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

.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Xavier IRIART, MD

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

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
  • breastfeeding women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Edge to edge repair of severe tricuspid regurgitation on a right systemic ventricle with a Mitraclip device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical, VO2 max testing, biological, echocardiographic, cross-sectionnal Imaging data.
Time Frame: 2 years
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.
Time Frame: 2 years
VO2 max testing: VO2 max (ml/min/kg), strenght in watts
2 years
Biological data.
Time Frame: 2 years
Biological data : hemoglobine (g/dL), hematocrit (%), creatinine (µmol/L), BNP/nt-proBNP (ng/mL) at baseline, 6, 12, 24 months
2 years
Echographic data.
Time Frame: 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
2 years
Cross-sectionnal Imaging data.
Time Frame: 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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bordeaux

Investigators

  • Principal Investigator: Alexandre SILINI, University Hospital, Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Anticipated)

October 30, 2022

Study Completion (Anticipated)

October 30, 2022

Study Registration Dates

First Submitted

September 2, 2021

First Submitted That Met QC Criteria

September 10, 2021

First Posted (Actual)

September 22, 2021

Study Record Updates

Last Update Posted (Actual)

September 22, 2021

Last Update Submitted That Met QC Criteria

September 10, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • University of Bordeaux

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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