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

NCT05089136 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 213

Last updated 2021-11-19

No results posted yet for this study

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

Conditions

  • Valvular Heart Disease
  • Valve Disease, Heart

Interventions

DEVICE

transcatheter paravalvular leak closure

Transcatheter paravalvular leak closure (PVLc) was first described in 1992 and has since then emerged as an attractive alternative to repeat surgery. Many implantable devices that can be used for transcatheter PVLc have been marketed, although few are specifically designed for this purpose. It consist in implanting an occluder in the paravalvular leak to stop or reduce the regurgitant flow.

Sponsors & Collaborators

  • Centre Chirurgical Marie Lannelongue

    lead OTHER

Principal Investigators

  • Benoit Gerardin · Hopital Marie Lannelongue

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2019-12-31
Completion
2021-12-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05089136 on ClinicalTrials.gov