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Transcatheter Para-Valvular Leak Closures

NCT05117359 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 366

Last updated 2021-11-11

No results posted yet for this study

Summary

Despite improvements in available techniques and prostheses, the long-term evolution of patients after transcatheter paravalvular leak closure remains poorly understood. The objective of this study is to evaluate the long-term outcome of patients after transcatheter paravalvular leak closure and to identify factors predictive of survival.

The investigators designed a retrospective multicentre observational registry entitled FFPP (e.g. "Fermeture des Fuites Para-Prothétiques" in French). Seventeen centres from France, Poland, Turkey and Belgium enrolled retrospectively at least one PVLc procedure on aortic, mitral, tricuspid or pulmonary valves without limit in its delay of performance.Follow-up of at least one year was expected

Conditions

  • Paravalvular Aortic Regurgitation
  • Paravalvular Mitral Regurgitation
  • Cardiac Valve Disease
  • Cardiac Catheterization

Interventions

DEVICE

transcatheter paravalvular leak closure

transcatheter paravalvular leak closure on cardiac valve

Sponsors & Collaborators

  • Centre Chirurgical Marie Lannelongue

    lead OTHER

Principal Investigators

  • Sebastien Hascoet, MD, PhD · Centre Chirurgical Marie Lannelongue

Eligibility

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

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2018-12-31
Completion
2020-01-01
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 NCT05117359 on ClinicalTrials.gov