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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)

France10 participantsStarted 2020-07-01

Plain-language 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 .

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Clinical, VO2 max testing, biological, echocardiographic, cross-sectionnal Imaging data.

Timeframe: 2 years

VO2 max testing data.

Timeframe: 2 years

Biological data.

Timeframe: 2 years

Echographic data.

Timeframe: 2 years

Cross-sectionnal Imaging data.

Timeframe: 2 years

Trial details

NCT IDNCT05052177

SponsorUniversity of Bordeaux

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-10-30

Contact for this trial

Alexandre SILINI

0678746867 alexandre.silini@gmail.com

View on ClinicalTrials.gov More Systemic Right Ventricle trials