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Evaluation of the Usefulness of Imaging Methods and 3D Reconstruction in Percutaneous Closure Procedures of PVL.

NCT03371472 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2019-01-17

No results posted yet for this study

Summary

Paravalvular leak (PVL) is a condition that could be treated surgically or by the transcatheter deployment of the occluder devices (plugs).

No PVL-specific occluder device is available on the market. VALE consortium plans to design and validate a new PVL dedicated devices (sizing balloon and occluder) in the context of computer 3D modeling, bench testing, preclinical evaluation and clinical research.

Conditions

  • PVL - Paravalvular Leak

Interventions

DEVICE

Visualisation and measuring of paravalvular leak.

Visualisation and measurements of PVL by investigational sizing ballons made by Balton. The balloon is a modification of diameter and length of existing sizing ballons (AcuMark™, AMPLATZER™, Occlutech®).

Sponsors & Collaborators

  • KCRI

    collaborator OTHER

  • Balton Sp.zo.o.

    lead INDUSTRY

Principal Investigators

  • Wojciech Wojakowski, Prof. · III Oddział Kardiologii, Samodzielny Publiczny Szpital Kliniczny nr 7 Śląskiego Uniwersytetu Medycznego w Katowicach, Górnośląskie Centrum Medyczne im. prof. Leszka Gieca

Study Design

Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-08
Primary Completion
2018-06-12
Completion
2018-07-14

Countries

  • Poland

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 NCT03371472 on ClinicalTrials.gov