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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)

Sponsor
University of Bordeaux (Other)
Overall Status
Recruiting
CT.gov ID
NCT05052177
Collaborator
(none)
10
Enrollment
1
Location
28
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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

.

Condition or Disease Intervention/Treatment Phase
  • Device: Edge to edge repair in systemic tricuspid valve regurgitation

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 Design

Study Type:
Observational
Anticipated Enrollment :
10 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
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.
Actual Study Start Date :
Jul 1, 2020
Anticipated Primary Completion Date :
Oct 30, 2022
Anticipated Study Completion Date :
Oct 30, 2022

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Clinical, VO2 max testing, biological, echocardiographic, cross-sectionnal Imaging data. [2 years]

    Clinical data : dyspnea (NYHA 1/2/3/4), heart palpitations (yes/no), heart failure in the 6 previous months (yes/no)

  2. VO2 max testing data. [2 years]

    VO2 max testing: VO2 max (ml/min/kg), strenght in watts

  3. Biological data. [2 years]

    Biological data : hemoglobine (g/dL), hematocrit (%), creatinine (µmol/L), BNP/nt-proBNP (ng/mL) at baseline, 6, 12, 24 months

  4. Echographic data. [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

  5. Cross-sectionnal Imaging data. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bordeaux University Hospital Bordeaux France 33000

Sponsors and Collaborators

  • University of Bordeaux

Investigators

  • Principal Investigator: Alexandre SILINI, University Hospital, Bordeaux

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Alexandre Silini, Intern, University of Bordeaux
ClinicalTrials.gov Identifier:
NCT05052177
Other Study ID Numbers:
  • University of Bordeaux
First Posted:
Sep 22, 2021
Last Update Posted:
Sep 22, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Tricuspid Valve Insufficiency

Study Results

No Results Posted as of Sep 22, 2021