UnknownNot Applicable

Transcatheter Para-Valvular Leak Closure: An International Prospective Multicentre Registry

213 participantsStarted 2017-01-01

Plain-language summary

Prosthetic paravalvular leaks (PVL) leading to heart failure and/or haemolysis can be treated by interventional cardiology or open-heart surgery. Predictors of clinical success of transcatheter closure remains little known and should be identified to help choose between these two options.Patient selection criteria for the best option are needed. The investigators aimed to identify predictors of clinical success after transcatheter PVL closure. Consecutive patients referred to 24 European centres for transcatheter PVL closure in 2017-2019 were included in a prospective registry (Fermeture de Fuite ParaProthétique, FFPP) and followed over 2 years

Who can participate

Age range18 Years – 100 Years

SexALL

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Inclusion Criteria: All centres included consecutive patients referred for PVLc. Patients were selected for transcatheter PVLc as opposed to first-line surgical PVLc if they were at high or prohibitive surgical risk or as an alternative option to surgery if transcatheter PVLc feasibility was high. Patients were selected by each heart-team of participating centre according to local practice.

What they're measuring

Death or secondary valve replacement

Timeframe: 2 years

Trial details

NCT IDNCT05089136

SponsorCentre Chirurgical Marie Lannelongue

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-12-31

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