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)
NCT ID: NCT05052177
Last Updated: 2021-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
10 participants
OBSERVATIONAL
2020-07-01
2022-10-30
Brief Summary
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It's an observationnal study with a 2 years follow up with clinical (symptoms, complications, VO2 exercice test) echographic and MRI outcomes
.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* breastfeeding women
18 Years
ALL
No
Sponsors
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University of Bordeaux
OTHER
Responsible Party
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Alexandre Silini
Intern
Principal Investigators
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Alexandre SILINI
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
Locations
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Bordeaux University Hospital
Bordeaux, , France
Countries
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Central Contacts
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Xavier IRIART, MD
Role: CONTACT
Facility Contacts
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Related Links
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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.
Other Identifiers
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University of Bordeaux
Identifier Type: -
Identifier Source: org_study_id
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