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European Multicentre Registry of Percutaneous Paravalvular Leak Closure

NCT05506293 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2022-08-18

No results posted yet for this study

Summary

Paraprosthetic cardiac valve leaks are a progressive complication after after surgical or percutaneous heart valve replacement. These leaks can lead to heart failure and/or life-threatening hemolysis.

Percutaneous closure of para-prosthetic leaks has been developed as an alternative to surgery in high-risk patients. These procedures remain technically challenging with a significant risk of failure and complications, but this risk is improved since the development of dedicated prostheses and the increased experience of the operators. The data in the literature concerning percutaneous leak closure remain limited and disparate and mostly retrospective.The impact of the procedures on the quality of life of patients is not known. Beyond the technical aspects and the follow-up of major cardiovascular events, investigators also wonder what is the impact of these procedures on the quality of life of patients. Investigators hypothesize that even a partial reduction in paraprosthetic leakage may be associated with an improvement in quality of life through reduction of transfusion needs and/or reduction of dyspnea. A prospective study is warranted to assess the technical and clinical and clinical results of these procedures, together with the evaluation of the the possible benefit on the quality of life of the patients.

Conditions

  • Cardiac Valve Disease
  • Paravalvular Aortic Regurgitation
  • Paravalvular Mitral Regurgitation
  • Paravalvular Leak
  • Quality of Life
  • Outcomes

Interventions

PROCEDURE

percutaneous paravalvular leak closure

the procedure consists of deployment of an occluder or a vascular plug within the cardiac paravalvular leak. The device is inserted percutaneously from a femoral vascular approach or from a trans-apical approach. The device is deployed through a delivery sheath within the leak. Stability and efficacy to occlude the leak are assessed by transoesophageal echocardiography prior to device release. Type of devices to be inserted varied : * Amplatzer vascular plug 3 * occlutech paravalvular leak device * amplatzer vascular plug 2 * amplatzer muscular ventricular septal defect * amplatzer vascular plug 4 Devices to be implanted are under the responsability of the local investigator and are not based on the study design.

Sponsors & Collaborators

  • Easy-CRF

    collaborator UNKNOWN

  • Centre Chirurgical Marie Lannelongue

    lead OTHER

Principal Investigators

Eligibility

Min Age
16 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2024-12-31
Completion
2026-07-01

Countries

  • Belgium
  • Czechia
  • France
  • Greece
  • Italy
  • Latvia
  • Lithuania
  • Mexico
  • Poland
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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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 NCT05506293 on ClinicalTrials.gov